Ticarcillin Sodium may be available in the countries listed below.
Ticarcillin Sodium (BANM, JAN) is known as Ticarcillin in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| JAN | Japanese Accepted Name |
Patcon may be available in the countries listed below.
Pentoxyverine citrate (a derivative of Pentoxyverine) is reported as an ingredient of Patcon in the following countries:
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Insuman N may be available in the countries listed below.
Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insuman N in the following countries:
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Iramox may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Iramox in the following countries:
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See also: Generic Apidra Solostar
Apidra is a brand name of insulin glulisine, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Apidra available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Apidra. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Parol may be available in the countries listed below.
Paracetamol is reported as an ingredient of Parol in the following countries:
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Treating symptoms of low testosterone in adult men when their bodies do not make any testosterone or not enough testosterone (hypogonadism). It may be used for other conditions as determined by your doctor.
Striant is a male sex hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Striant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Striant. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Striant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Striant as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Striant.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Acne; bitter or strange taste in mouth; change in sex drive; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; dark urine or light-colored bowel movements; depression or mood changes; dizziness; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; stomach pain; swelling of the ankles or legs; urination problems; weight gain; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Striant side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; one-sided weakness; vision problems.
Store Striant at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Do not use a damaged blister package. Throw Striant away in a household trash can in a way that prevents children or pets from accidentally using or taking them.
Keep Striant out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Striant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Normoten may be available in the countries listed below.
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Normoten in the following countries:
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Tenaline may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Oxytetracycline is reported as an ingredient of Tenaline in the following countries:
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Generic Name: esterified estrogens and methyltestosterone (ess TER if fyed ESS troe jenz and METH il tes TOS te rone)
Brand Names: Covaryx, Covaryx HS, EEMT, EEMT DS, EEMT HS, Essian, Essian H.S., Estratest, Estratest H.S.
Esterified estrogens are female sex hormones necessary for many processes in the body.
Methyltestosterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.
The combination of esterified estrogens and methyltestosterone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.
This medication may also be used for purposes not listed in this medication guide.
Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are taking esterified estrogens and methyltestosterone.
Long-term esterified estrogens and methyltestosterone treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.
You should not take esterified estrogens and methyltestosterone if you have:
a recent history of heart attack, stroke or circulation problems;
abnormal vaginal bleeding that a doctor has not checked;
any type of breast, uterine, or hormone-dependent cancer; or
if you are pregnant or breast-feeding.
To make sure you can safely take esterified estrogens and methyltestosterone, tell your doctor if you have any of these other conditions:
high blood pressure, heart disease, or coronary artery disease;
high cholesterol or triglycerides;
asthma;
epilepsy or other seizure disorder;
migraines;
endometriosis;
diabetes;
lupus;
depression;
gallbladder disease;
if you smoke; or
if you have had your uterus removed (hysterectomy).
Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using esterified estrogens and methyltestosterone.
Long-term esterified estrogens and methyltestosterone treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
This medication is usually taken in a cycle of 3 weeks on and 1 week off. Follow your doctor's instructions.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, or vaginal bleeding.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden severe headache, confusion, problems with vision, speech, or balance;
swelling, rapid weight gain;
confusion, unusual thoughts or behavior;
pain, swelling, or tenderness in your stomach;
nausea, stomach pain, loss of appetite jaundice (yellowing of the skin or eyes);
breast lump, nipple discharge;
acne, skin color changes, increased facial hair, male pattern baldness, voice changes; or
changes in your menstrual periods, break-through bleeding.
Less serious side effects may include:
mild nausea, stomach upset;
swollen or painful breasts;
headache;
hair loss;
depression, anxiety; or
decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Many drugs can interact with esterified estrogens and methyltestosterone. Below is just a partial list. Tell your doctor if you are using:
a blood thinner such as warfarin (Coumadin);
insulin;
ketoconazole (Nizoral);
St. John's wort;
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
an antidepressant;
seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;
an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, Erythrocin), telithromycin (Ketek), and others; or
HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir, Kaletra).
This list is not complete and other drugs may interact with esterified estrogens and methyltestosterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: EEMT DS side effects (in more detail)
Ibupal may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibupal in the following countries:
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Algex may be available in the countries listed below.
Mefenamic Acid is reported as an ingredient of Algex in the following countries:
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Zaldaks may be available in the countries listed below.
Paracetamol is reported as an ingredient of Zaldaks in the following countries:
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Panadol Menstrual may be available in the countries listed below.
Pamabrom is reported as an ingredient of Panadol Menstrual in the following countries:
Paracetamol is reported as an ingredient of Panadol Menstrual in the following countries:
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Triaxon may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Triaxon in the following countries:
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Waxsol may be available in the countries listed below.
UK matches:
Docusate Sodium is reported as an ingredient of Waxsol in the following countries:
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Lorexane may be available in the countries listed below.
Lindane is reported as an ingredient of Lorexane in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Lasalocid is reported as an ingredient of Iono Lyx in the following countries:
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Nafordyl may be available in the countries listed below.
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Nafordyl in the following countries:
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Meloxicam Farmoz may be available in the countries listed below.
Meloxicam is reported as an ingredient of Meloxicam Farmoz in the following countries:
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Modalina may be available in the countries listed below.
Trifluoperazine hydrochloride (a derivative of Trifluoperazine) is reported as an ingredient of Modalina in the following countries:
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Iberol may be available in the countries listed below.
Ferrous Sulfate is reported as an ingredient of Iberol in the following countries:
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Ificef may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Ificef in the following countries:
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The following drugs and medications are in some way related to, or used in the treatment of Acute Myeloid Leukemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Micromedex Care Notes:
Medical Encyclopedia:
Harvard Health Guide:
Class: Biologic Response Modifiers
VA Class: IM700
Chemical Name: Disulfide with human-mouse monoclonal AN100226 light chain immunoglobulin G 4 (human-mouse monoclonal AN100226 4-chain anti-human integrin 4) dimer
CAS Number: 189261-10-7
Brands: Tysabri
Special Alerts:
[UPDATED Posted 04/22/2011] FDA has updated the natalizumab (Tysabri) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of natalizumab for the treatment of multiple sclerosis (MS) and Crohn's disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. Natalizumab, in a class of medications called immunomodulators, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008. The revised label includes a table summarizing rates of PML with natalizumab use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor. For more information visit the FDA website at: and .
REMS:
FDA approved a REMS for natalizumab to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of natalizumab and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().
Increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain; usually leads to death or severe disability.1 13 14 15 16 (See Progressive Multifocal Leukoencephalopathy under Cautions.)
PML cases reported in patients receiving natalizumab who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving natalizumab monotherapy.1
Because of risk of PML, available only through a restricted distribution program (TOUCH Prescribing Program).1 2 3 (See Restricted Distribution Program under Dosage and Administration.)
Monitor patients during therapy for any new signs or symptoms suggestive of PML; immediately withhold the drug at first such sign or symptom.1
For diagnosis of PML, an evaluation that includes a gadolinium-enhanced MRI brain scan and, when indicated, CSF analysis for JC viral DNA recommended.1
Biologic response modifier; a recombinant humanized anti-α4-integrin monoclonal antibody.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Treatment of relapsing-remitting multiple sclerosis (MS).1 Used as monotherapy to delay accumulation of physical disability and reduce frequency of clinical exacerbations.1
Safety and efficacy in patients with chronic progressive MS not established.1
Safety in conjunction with other biologic response modifiers used in treatment of MS (e.g., glatiramer acetate, interferon beta-1a) not established.1 8 13 25
Safety and efficacy for long-term use (i.e., >2 years) not established.1
Because of risk of PML, generally recommended only in patients who have had an inadequate response to or are unable to tolerate other MS therapies.1 (See Progressive Multifocal Leukoencephalopathy under Cautions.) In addition, available only through restricted distribution program.1 2 3 (See Restricted Distribution Program under Dosage and Administration.)
Used to induce and maintain clinical response and remission in adults with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to or who do not tolerate conventional therapies and inhibitors of tumor necrosis factor (TNF; TNF-α).1 21 22 23 24 26 28
Do not use in combination with immunosuppressants (e.g., mercaptopurine, azathioprine, cyclosporine, methotrexate) or TNF inhibitors in patients with Crohn's disease, because of potential for increased risk of PML and other infections. (See Progressive Multifocal Leukoencephalopathy under Cautions and see Immunosuppression and Infectious Complications under Cautions.)1
Aminosalicylates may be used in patients receiving natalizumab.1
Because of risk of PML (see Progressive Multifocal Leukoencephalopathy under Cautions.), available only through a restricted distribution program (TOUCH Prescribing Program).1 2 3
Clinicians, pharmacies, infusion centers, and patients must be registered with and meet all conditions of TOUCH program before they can prescribe, dispense, infuse, or receive natalizumab.1 2 3
TOUCH program was designed to assess the risk of PML associated with the drug, minimize risk of PML, minimize death and disability due to PML, and promote informed risk versus benefit decisions regarding use of the drug.3
Information about TOUCH program available at 800-456-2255 or .1 2
Administer by IV infusion.1 Do not administer by rapid IV injection.1
Vials are for single use only.1
Do not infuse or admix with any other drug.1
Use of filtration devices during IV infusion not evaluated.1
Allow solution to warm to room temperature prior to administration.1
Following completion of infusion, flush infusion set with 0.9% sodium chloride injection.1
Observe patients closely for signs or symptoms of hypersensitivity or infusion-related reactions during and for 1 hour after the IV infusion.1 (See Acute Infusion Reactions under Cautions.)
Use strict aseptic technique since drug product contains no preservatives.1
The concentrate for injection containing 300 mg/15 mL must be diluted in 0.9% sodium chloride prior to IV infusion.1 Do not use other IV diluents.1
Withdraw 15 mL of the concentrate from a single-use vial and add to 100 mL of 0.9% sodium chloride injection.1 Gently invert diluted solution to mix completely; do not shake.1
Administer IV infusions over approximately 1 hour.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
300 mg once every 4 weeks.1
Efficacy for long-term use (i.e., >2 years) not established.1
300 mg once every 4 weeks.1
In patients receiving chronic oral corticosteroid therapy, start tapering corticosteroid dosage as soon as a therapeutic benefit of natalizumab occurs.1 Discontinue natalizumab if patient cannot be tapered off oral corticosteroids within 6 months of initiating natalizumab.1 Consider discontinuing natalizumab in patients who require additional corticosteroid use that exceeds 3 months in a calendar year to control Crohn's disease other than the 6-month corticosteroid taper.1
Discontinue natalizumab if no therapeutic benefit is evident by 12 weeks of therapy.1
Safety of doses >300 mg not adequately evaluated; maximum safe dosage not determined.1
No special population recommendations at this time.1
Known hypersensitivity to natalizumab or any ingredient in the formulation.1
Current or previous history of PML.1 (See Progressive Multifocal Leukoencephalopathy under Cautions.)
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
PML, an opportunistic viral infection of the brain, reported in patients receiving natalizumab.1 13 14 15 16 32 34
PML is caused by the JC virus, typically occurs in immunocompromised patients (e.g., patients with HIV infection), and usually leads to death or severe disability.1 14 15 16 32 34
Estimated absolute risk for PML is 1 in 1000 patients.15 32 34
Risk of developing PML increases with the number of infusions received.1 32 34
Risk of developing PML also increased in patients who have received prior immunosuppressive therapy, regardless of natalizumab treatment duration.1 32
PML has been reported in patients receiving natalizumab who were recently or concomitantly treated with immunomodulators or immunosuppressants (i.e., interferon beta-1a in MS patients, infliximab and azathioprine in Crohn’s patients) and also has been reported in patients receiving natalizumab without concomitant immunomodulatory drugs.1 27
Do not use in patients receiving chronic immunosuppressant or immunomodulatory therapy or in those with systemic medical conditions that result in compromised immune systems.1 (See Specific Drugs under Interactions.)
Interventions that can reliably prevent or adequately treat PML not known; also not known whether early detection of PML and discontinuance of drug will mitigate the disease.1
Monitor patients for any new signs or symptoms suggestive of PML (i.e., progressive weakness on one side of the body; clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes);1 seizures and headache also reported rarely.32 33 36 The progression of deficits usually leads to death or severe disability over weeks or months.1 Withhold the drug immediately at the first such signs or symptoms.1
For diagnosis of PML, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) brain scan and, when indicated, CSF analysis for JC viral DNA recommended.1 If clinical suspicion remains despite an initial negative evaluation for PML, do not reinitiate natalizumab until the evaluation has been repeated and confirmed.1
Prior to initiating natalizumab in patients with MS, perform baseline MRI scan since this may help differentiate subsequent MS symptoms from PML.1
A baseline brain MRI scan may be useful in patients with Crohn's disease to distinguish preexisting lesions from newly developed lesions.1 Baseline brain lesions that could cause diagnostic difficulty in patients with Crohn's disease while on natalizumab treatment are uncommon.1
Immune reconstitution inflammatory syndrome (IRIS) has been reported in the majority of natalizumab-treated patients who discontinued the drug after developing PML;1 32 IRIS not reported to date when natalizumab discontinued for reasons unrelated to PML.1 32
IRIS is a severe inflammatory response occurring during or after immune system recovery; usually presents as clinical decline (sometimes after apparent clinical improvement) and may progress rapidly, leading to serious neurologic complications or death.1 32 34 36 In MS patients with PML who developed IRIS after discontinuing natalizumab, IRIS generally developed within days to several weeks after the patient received plasma exchange or immunoadsorption to enhance natalizumab removal.1 32 34
Monitor patients for development of IRIS; if IRIS occurs, treat the associated inflammation as appropriate (e.g., corticosteroids).1 32 34 36
Promptly report any case of PML, serious opportunistic infection, atypical infection, or death to Biogen Idec at 800-456-2255 and to FDA’s MedWatch program at 800-332-1088.1 3 32
Serious hypersensitivity reactions (e.g., anaphylaxis/anaphylactoid reaction) reported in <1% of patients;1 10 11 usually occurred within 2 hours after initiation of IV infusion and generally associated with antibodies to the drug.1 (See Antibody Formation under Cautions.)
If hypersensitivity reactions (e.g., anaphylaxis, urticaria, dizziness, fever, rash, rigors, pruritus, nausea, flushing, hypotension, dyspnea, chest pain) occur, discontinue immediately and initiate appropriate therapy.1
Do not reinitiate in any patient who experienced a hypersensitivity reaction to the drug.1
Consider possibility of anti-natalizumab antibodies in patients who have hypersensitivity reactions.1
Antibodies to natalizumab may develop.1 10
Antibodies against natalizumab may be neutralizing and persistent antibody-positivity may be associated with decreased natalizumab serum concentrations, decreased efficacy, increased rate of myalgia, hypertension, dyspnea, anxiety and tachycardia, and increased risk of infusion-related reactions.1 (See Acute Infusion Reactions under Cautions.)
Long-term immunogenicity remains to be determined; effects of low to moderate levels of antibodies against natalizumab not known.1 Experience with monoclonal antibodies (e.g., natalizumab) suggests that patients who receive therapeutic antibodies after an extended period without such treatment may be at higher risk of hypersensitivity reactions than patients who receive regularly scheduled treatment; not known if this will occur with natalizumab.1
Consider testing for presence of antibodies to natalizumab in patients who wish to resume treatment following an interruption in therapy.1 Patients who have tested negative for antibodies against natalizumab prior to retreatment have a risk of antibody development with retreatment that is similar to natalizumab-naive patients.1
Perform sequential antibody testing if presence of persistent antibodies suspected.1 Antibodies detected early in treatment course (e.g., within first 6 months) may be transient and disappear with continued use; repeat testing at 3 months after initial positive result to confirm persistent antibodies.1
Consider overall benefits and risks of the drug in patients who have persistent antibodies.1
Possible infusion-related reactions within 2 hours after initiation of infusion in patients with MS1 10 or Crohn's disease.1
In patients with MS, headache, dizziness, fatigue, urticaria, pruritus, and rigors reported more frequently in patients receiving the drug compared with those receiving placebo, while in patients with Crohn's disease, headache, nausea, urticaria, pruritus, and flushing reported more frequently in patients receiving the drug compared with those receiving placebo.1
Most reactions were treated symptomatically; patients recovered with such treatment and/or discontinuance of the infusion.1 10
Infusion-related reactions reported more frequently in patients persistently positive for anti-natalizumab antibodies.1 (See Antibody Formation under Cautions.) Infusion-related reactions usually associated with persistent antibody-positivity include urticaria, rigors, nausea, vomiting, headache, flushing, dizziness, pruritus, tremor, feeling cold, and pyrexia.1
Possible increased risk of infections, including opportunistic infections.1
PML, an opportunistic viral infection of the brain that usually is fatal or associated with severe disability, reported in patients receiving natalizumab.1 (See Progressive Multifocal Leukoencephalopathy under Cautions.)
Pneumonia (sometimes severe), urinary tract infections (sometimes severe), influenza, gastroenteritis, vaginal infections, tooth infections, tonsillitis or pharyngitis, and herpes infections reported in MS patients.1 10 Most infections were mild to moderate10 and did not require interruption of therapy.1 10 At least 1 case of cryptosporidial gastroenteritis with a prolonged course reported in an MS patient receiving natalizumab.1
Increased incidence of infections observed in patients receiving short courses of corticosteroids concomitantly with natalizumab; however, incidence in those receiving corticosteroids concomitantly with placebo was similar.1
Pneumocystis jiroveci (formerly P. carinii) pneumonia, pulmonary Mycobacterium avium complex (MAC) infections, bronchopulmonary aspergillosis, and Burkholderia cepacia infection reported rarely in patients with Crohn’s disease.1 Increased incidence of infection observed in those receiving corticosteroids concomitantly with natalizumab; however, incidence in those receiving corticosteroids concomitantly with placebo was similar.1
Herpes encephalitis (resulting in death) and herpes meningitis reported in postmarketing experience in patients with MS.1
Concomitant use of natalizumab and antineoplastic agents, immunosuppressive agents, or immunomodulating agents may further increase risk of infections, including PML and other opportunistic infections.1 Safety and efficacy of natalizumab in combination with antineoplastic agents, immunosuppressive agents, or immunomodulating agents not established.1 (See Specific Drugs under Interactions.)
Clinically important liver dysfunction (e.g., elevated hepatic enzymes, elevated total bilirubin) reported as early as 6 days after administration of the first dose of natalizumab and also after multiple doses.1 30 Liver dysfunction may recur upon rechallenge indicating that natalizumab caused the injury.1
Elevated transaminase levels together with elevated bilirubin (without evidence of obstruction) generally is recognized as an important predictor of severe liver injury that may lead to death or the need for liver transplantation.1 30
Discontinue natalizumab in patients with jaundice or other evidence of clinically important liver injury (e.g., laboratory evidence).1 30
Reversible increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells reported; increases usually persisted during treatment but returned to baseline within 16 weeks after last dose.1 10 11 Increases in neutrophil counts not reported.1 10 11
Mild, transient decreases in hemoglobin levels reported.1
Category C.1 Pregnancy registry at 800-456-2255.1
Natalizumab is distributed into milk;1 potential for serious adverse reactions in nursing infants.1 Discontinue nursing or the drug.1
Safety and efficacy not established in patients <18 years of age with MS or Crohn's disease.1 Not indicated for use in pediatric patients.1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
Clinically important liver dysfunction reported in patients receiving natalizumab.1 (See Hepatotoxicity under Cautions.)
Not studied in patients with renal impairment.1
Patients with MS: Headache,1 fatigue,1 infusion-related reactions,1 arthralgia or extremity pain,1 depression,1 lower respiratory or urinary tract infections,1 gastroenteritis,1 rash,1 vaginitis,1 abdominal discomfort,1 diarrhea.1
Patients with Crohn's disease: Headache,1 fatigue,1 upper respiratory infection,1 nausea.1
Drug | Interaction | Comments |
|---|---|---|
Corticosteroids | Increased incidence of infection1 | |
Immunosuppressive agents (e.g., azathioprine, cyclosporine, mercaptopurine, methotrexate) and TNF inhibitors | Potential for increased risk of PML and other infections 1 | Do not use concomitantly in patients with Crohn's disease1 Generally avoid natalizumab use in patients with MS receiving chronic immunosuppressive or immunomodulatory therapy1 |
Interferon beta | Potential increased natalizumab serum concentrations and half-life; no apparent effect on interferon beta-1a pharmacokinetics8 | Pharmacokinetic interaction may not be clinically important8 Safety of concomitant interferon beta not established1 |
Vaccines | Data not available on effects of vaccination, including secondary transmission of infection from live viral vaccines, in patients receiving natalizumab1 |
Mean half-life is 11 days.1
Clearance increases with body weight in less than proportional manner.1
Presence of persistent anti-natalizumab antibodies appears to increase drug clearance approximately threefold.1 (See Antibody Formation under Cautions.)
2–8°C; protect from light.1 Do not shake or freeze.1
Following dilution, infuse immediately or refrigerate at 2–8°C and use within 8 hours.1 Do not freeze diluted solution.1
For information on systemic interactions resulting from concomitant use, see Interactions.
Compatible |
|---|
Sodium chloride 0.9% |
Mechanism of action in MS not fully elucidated; may involve blockade of α4β1 integrin-mediated leukocyte migration from peripheral blood into CNS.1 5 18
Binds specifically to α4-subunits of α4β1 and α4β7 integrins expressed on the surface of all leukocytes (except neutrophils) and inhibits α4-mediated adhesion of leukocytes to their counterreceptors, including vascular cell adhesion molecule-1 (VCAM-1).1 5
May also block α4-mediated cell binding to ligands such as osteopontin and CS-1 of fibronectin.1
In Crohn's disease, interaction of α4β7 integrin with the endothelial receptor mucosal addressin cell adhesion molecule-1 (MAdCAM-1) implicated as an important contributor to the chronic inflammation of the disease.1 MAdCAM-1 expression found to be increased at active sites of inflammation suggesting that it may play a role in the recruitment of leukocytes to mucosa and contribute to the inflammatory response characteristic of the disease.1
Mechanism of action in Crohn's disease not fully elucidated; may involve blockade of the interaction of α4β7 integrin receptor with MAdCAM-1 expressed on the vascular endothelium at inflammatory foci.1
Importance of patients being counseled on and understanding the benefits and risks of natalizumab before the initial prescription is written.1
Provide natalizumab medication guide to the patient; importance of patient reading the medication guide prior to initiating natalizumab therapy and before each dose of the drug.1 4
Importance of promptly informing clinicians of any new or worsening symptoms that persist over several days.1
Advise patients that they will need to be evaluated by their prescriber at 3 and 6 months after the first natalizumab infusion and at least once every 6 months during therapy.1
Importance of informing patients that PML has occurred in patients treated with natalizumab and that PML usually leads to death or severe disability over weeks or months.1 Patients must understand the signs and symptoms and risk of PML and contact their clinician if they develop any symptoms of PML.1
Importance of promptly informing clinicians of any new or worsening symptoms suggestive of PML (e.g., progressive weakness on one side of the body; clumsiness of limbs; disturbance of vision; changes in thinking, memory, personality, orientation leading to confusion) that have progressed over days to weeks.1 4
Importance of patients informing all their clinicians that they are receiving natalizumab.1 4
Importance of discontinuing natalizumab and reporting any symptoms consistent with a hypersensitivity reaction (e.g., urticaria, pruritus, difficulty breathing) that occur during or following IV infusion of the drug.1 4
Importance of informing patients that natalizumab may increase risk of infection and of informing clinicians if fever or infection (including shingles or any unusually long-lasting infection) occurs.1 4
Risk of liver injury; importance of contacting clinician if symptoms of hepatotoxicity develop.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 4
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 4
Importance of informing patients of other important precautionary information.1 4 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Natalizumab available only through a restricted distribution program (TOUCH Prescribing Program).1 (See Restricted Distribution Program under Dosage and Administration.)
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, concentrate, for IV infusion only | 300 mg/15 mL | Tysabri | Elan |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Biogen Idec. Tysabri (natalizumab) prescribing information. Cambridge, MA; 2010 July
2. Food and Drug Administration. Questions and Answers on natalizumab (marketed as Tysabri). From the FDA website. Accessed 2006 Jul 6.
3. Food and Drug Administration. Tysabri risk minimization action plan: summary of Touch. From FDA website. Accessed 2006 Jul 6.
4. Biogen Idec. Tysabri (natalizumab) medication guide. Cambridge, MA; 2010 July
5. Anon. Natalizumab: AN 100226, anti-4alpha integrin monoclonal antibody. Drugs R&D. 2004; 5: 102-7.
6. Goodin DS. The return of natalizumab: weighing benefit against risk. Lancet. 2006; 5:375-7.
7. Goodin DS, Frohman EM, Garmany GP Jr et al. Disease modifying therapies in multiple sclerosis: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology and the MS council for clinical practice guidelines. Neurology. 2002; 58:169-178. [IDIS 475332] [PubMed 11805241]
8. Vollmer TL, Phillips JT, Goodman AD et al. An open-label safety and drug interaction study of natalizumab (Antegren) in combination with interferon-beta (Avonex) in patients with multiple sclerosis. Mult Scler. 2004; 10:511-20. [PubMed 15471366]
9. Rice GP, Hartung HP, Calabresi PA. Anti-α4 integrin therapy for multiple sclerosis: mechanisms and rationale. Neurology. 2005; 64:1336-42. [PubMed 15851719]
10. Polman CH, O’Connor PW, Havrdova E et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006; 354:899-910. [PubMed 16510744]
11. Miller DH, Khan OA, Sheremata WA et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2003; 348:15-23. [PubMed 12510038]
12. O’Connor PW, Goodman A, Willmer-Hulme AJ et al. Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects. Neurology. 2004; 62:2038-43. [PubMed 15184611]
13. Rudick RA, Stuart WH, Calabresi PA et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006; 354:911-23. [PubMed 16510745]
14. Langer-Gould A, Atlas SW, Green AJ et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med. 2005; 353:375-81. [PubMed 15947078]
15. Yousry TA, Major EO, Ryschkewitsch C et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med. 2006; 354:924-33. [PubMed 16510746]
16. Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005; 353:369-74. [PubMed 15947079]
17. Van Assche G, Van Ranst M, Sciot R et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn’s disease. N Engl J Med. 2005; 353:362-8. [PubMed 15947080]
18. Niino M, Bodner C, Simard ML et al. Natalizumab effects on immune cell responses in multiple sclerosis. Ann Neurol. 2006; 59:748-54. [PubMed 16634035]
19. Stuve O, Marra CM, Jerome KR et al. Immune surveillance in multiple sclerosis patients treated with natalizumab. Ann Neurol. 2006; 59:743-7. [PubMed 16634029]
20. Food and Drug Administration. Natalizumab in combination with glatiramer acetate (GA) in patients with relapsing-remitting multiple sclerosis. From FDA clinical trials website. Accessed 2006 July 10.
21. Gordon FH, Lai CWY, Hamilton MI et al. A randomized placebo-controlled trial of a humanized monoclonal antibody to α4 integrin in active Crohn’s disease. Gastroenterology. 2001; 121:268-74. [PubMed 11487536]
22. Ghosh S, Goldin E, Gordon FH et al. Natalizumab for active Crohn’s disease. N Engl J Med. 2003; 348:24-32. [IDIS 491214] [PubMed 12510039]
23. Sandborn WJ, Colombel JF, Enns R et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2005; 353:1912-5. [PubMed 16267322]
24. MacDonald JK, McDonald JWD. Natalizumab for induction of remission of Crohn’s disease. Cochrane Database Syst Rev. 2006; 3:CD006097.
25. Biogen Idec, San Diego, CA and Cambridge, MA: Personal communication.
26. Targan SR, Feagan BG, Fedorak RN et al. Natalizumab for the treatment of active Crohn's disease: results of the ENCORE trial. Gastroenterology. 2007; 132:1672-83. [PubMed 17484865]
27. Food and Drug Administration. Information for Healthcare Professionals: Natalizumab injection for intravenous use (marketed as Tysabri). 2008 Aug. From FDA website.
28. Food and Drug Administration. Natalizumab (Tysabri) for Crohn's Disease (CD) briefing book. 2007 Jun 21. From FDA website.
29. Food and Drug Administration. FDA news. FDA approves Tysabri to treat moderate-to-severe Crohn's disease. 2008 Jan 14. From FDA website.
30. Food and Drug Administration. MedWatch: 2008 safety information alerts. Tysabri (natalizumab). 2008 Feb. From FDA website.
31. Best WR, Becktel JM, Singleton JW et al. Development of a Crohn’s disease activity index: National Cooperative Crohn’s Disease Study. Gastroenterology. 1976; 70:439-44 [PubMed 1248701]
32. Food and Drug Administration. FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab). 2010 Feb. From FDA website.
33. Foley J. Recommendations for the selection, treatment, and management of patients utilizing natalizumab therapy for multiple sclerosis. Am J Manag Care. 2010; 16(6 Suppl):S178-83. [PubMed 20615054]
34. Clifford DB, De Luca A, DeLuca A et al. Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol. 2010; 9:438-46. [PubMed 20298967]
35. Steiner I. PML: underdiagnosed in MS patients on natalizumab. Lancet Neurol. 2010; 9:564; author reply 564-5. [PubMed 20494319]
36. Tan CS, Koralnik IJ. Progressive multifocal leukoencephalopathy and other disorders caused by JC virus: clinical features and pathogenesis. Lancet Neurol. 2010; 9:425-37. [PubMed 20298966]
Sulfaméthoxazole may be available in the countries listed below.
Sulfaméthoxazole (DCF) is known as Sulfamethoxazole in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Interferon Alfa-2b Humano Recombinante may be available in the countries listed below.
Interferon alfa Interferon alfa-2b (Arg-23; His-34) (a derivative of Interferon alfa) is reported as an ingredient of Interferon Alfa-2b Humano Recombinante in the following countries:
International Drug Name Search
Tansulosina Jaba may be available in the countries listed below.
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tansulosina Jaba in the following countries:
International Drug Name Search
Insulin Penmix 40 may be available in the countries listed below.
Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Insulin Penmix 40 in the following countries:
International Drug Name Search
