Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 300mg/15mL

Multiple Sclerosis

Indicated as monotherapy for patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

300 mg IV infusion q4wk

When initiating and continuing treatment, consider whether expected benefit is sufficient to offset risk of PML

Crohn Disease

Indicated for moderate-to-severe Crohn disease in adults who had inadequate/intolerant response to conventional treatment and TNF-alpha inhibitors

300 mg IV q4wk

Dosing Considerations

Because natalizumab increases risk of progressive multifocal leukoencephalopathy (PML), it is recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy

Additional or previous immunosuppressive therapy increases risk for PML; therefore, do not administer concomitantly with immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or TNF-alpha inhibitors

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and natalizumab

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      Serious - Use Alternative

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              Serious - Use Alternative (12)

              • baricitinib

                baricitinib, natalizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

              • beclomethasone, inhaled

                beclomethasone, inhaled increases toxicity of natalizumab by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating natalizumab, taper of steroids patients receiving chronic corticosteroids .

              • certolizumab pegol

                natalizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

              • ifosfamide

                ifosfamide, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • influenza virus vaccine quadrivalent, adjuvanted

                natalizumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                natalizumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • lomustine

                lomustine and natalizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • mechlorethamine

                mechlorethamine, natalizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • melphalan

                melphalan, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • ocrelizumab

                ocrelizumab increases toxicity of natalizumab by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.

              • procarbazine

                procarbazine, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.

              • vedolizumab

                vedolizumab, natalizumab. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration because of the potential for increased risk of PML and other infections.

              Monitor Closely (12)

              • belatacept

                belatacept and natalizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cabazitaxel

                natalizumab and cabazitaxel both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant use of natalizumab and immunosuppressive agents should be avoided.

              • denosumab

                natalizumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fingolimod

                natalizumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • hydroxyurea

                natalizumab, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Potential for increased risk of concurrent infection.

              • meningococcal group B vaccine

                natalizumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • ofatumumab SC

                ofatumumab SC, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                natalizumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • ponesimod

                ponesimod and natalizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                natalizumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                trastuzumab, natalizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, natalizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              Minor (1)

              • interferon beta 1a

                interferon beta 1a increases levels of natalizumab by decreasing renal clearance. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Fatigue (10%)

              Diarrhea (10%)

              Urinary urgency/frequency (9%)

              Sinusitis (8%)

              Vaginal infections (8%)

              Arthralgia (8%)

              Cough (3-7%)

              Viral infection (7%)

              Dermatitis (7%)

              Pharyngolaryngeal pain (6%)

              Peripheral edema (6%)

              Rash (6%)

              Dysmenorrhea (2-6%)

              Vertigo (6%)

              Dyspepsia (5%)

              Abnormal liver function test (5%)

              Irregular menstruation (5%)

              Urinary incontinence (4%)

              Toothache (4%)

              Pruritus (4%)

              Lower abdominal pain (4%)

              Constipation (4%)

              Vaginal infections (4%)

              Limb injury (3%)

              Viral infections (3%)

              Urinary tract infections (3%)

              Flatulence (3%)

              Skin laceration (2%)

              Aphthous stomatitis (2%)

              Amenorrhea (2%)

              Ovarian cyst (2%)

              Somnolence (2%)

              Acute hypersensitivity reactions (2%)

              Thermal burn (1%)

              Dry skin (1%)

              Tremor (1%)

              Night sweats (1%)

              Postmarketing Reports

              Hemolytic anemia

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              Warnings

              Black Box Warnings

              Increased risk of progressive multifocal leukoencephalopathy, an opportunistic viral infection of the brain caused by the JC virus in immunocompromised patients that usually leads to death or severe disability

              Immune reconstitution inflammatory syndrome may occur in patients who have developed PML; IRIS is a rare condition characterized by severe inflammatory response

              Because of the risk of PML, natalizumab is available only through a special restricted distribution program under a risk evaluation and mitigation strategy (REMS); prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program, are able to prescribe, distribute, or infuse the product to patients who are enrolled in and meet all the conditions of the TOUCH Prescribing Program

              Healthcare professionals should monitor patients on natalizumab for any new sign or symptom that may be suggestive of PML

              Withhold dose immediately at the first sign or symptom suggestive of PML

              For diagnosis, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended

              Consider assessing anti-JCV antibody status prior to treatment or during treatment if antibody status is unknown; the Stratify JCV Antibody ELISA test (Focus Diagnostics) was cleared by FDA on January 20, 2012

              Factors known to increase risk of PML in natalizumab-treated patients

              • Longer treatment duration, especially beyond 2 years
              • Prior treatment with an immunosuppressant (eg, mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate)
              • Presence of anti-JCV antibodies
              • Patients with all 3 known risk factors have an estimated risk of PML of 11/1,000
              • The risks and benefits of continuing treatment with natalizumab should be carefully considered in patients who are found to be anti-JCV antibody positive and have 1 or more additional risk factors
              • PML has been reported following discontinuation in patients who did not have findings suggestive of PML at the time of discontinuation; continue to monitor for any new signs or symptoms that may be suggestive of PML for ~6 months following discontinuation

              Contraindications

              Hypersensitivity

              Active/history of progressive multifocal leukoencephalopathy

              Cautions

              Increased risk of PML with prolonged duration of therapy, prior treatment with immunosuppressants, or positive anti-JCV antibody status (see Black Box Warnings)

              Do not use with other immunosuppressives; may increase the risk for certain infections; monitor patients for development of infections

              Possibility of anaphylactic reaction; observe patients during and for 1 hr after infusion to see if symptoms of hypersensitivity-type reactions develop

              Herpes infections

              • Therapy increases risk of developing encephalitis and meningitis caused by herpes simplex and varicella-zoster viruses; serious, life-threatening, and sometimes fatal cases reported in the postmarketing setting in multiple sclerosis patients receiving therapy; laboratory confirmation in those cases was based on positive PCR for viral DNA in cerebrospinal fluid
              • The duration of treatment with drug prior to onset ranged from a few months to several years; monitor patients receiving drug for signs and symptoms of meningitis and encephalitis
              • If herpes encephalitis or meningitis occurs, discontinue therapy, and administer appropriate treatment for herpes encephalitis/meningitis

              Acute renal necrosis

              • Acute retinal necrosis (ARN) is a fulminant viral infection of retina caused by the family of herpesviruses (eg, varicella zoster, herpes simplex virus); a higher risk of ARN observed in patients being administered treatment
              • Patients presenting with eye symptoms, including decreased visual acuity, redness, or eye pain, should be referred for retinal screening for ARN; some ARN cases occurred in patients with central nervous system (CNS) herpes infections (eg, herpes meningitis or encephalitis)
              • Serious cases of ARN leading to blindness of one or both eyes reported in some patients; following clinical diagnosis of ARN, consider discontinuation of therapy; the treatment reported in ARN cases included anti-viral therapy and, in some cases, surgery

              Hepatotoxicity

              • Clinically significant liver injury, including acute liver failure requiring transplant, reported in patients treated in the postmarketing setting
              • Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, reported as early as six days after first dose; signs of liver injury have also been reported for the first time after multiple doses
              • In some patients, liver injury recurred upon rechallenge, providing evidence that treatment caused the injury; the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients
              • Therapy should be discontinued in patients with jaundice or other evidence of significant liver injury (eg, laboratory evidence)

              Progressive multifocal leukoencephalopathy

              • Infection by the JC virus is required for the development of PML; do not use anti-JCV antibody testing to diagnose PML; anti-JCV antibody negative status indicates that antibodies to the JC virus have not been detected; patients who are anti-JCV antibody negative have a lower risk of PML than those who are positive; patients who are anti-JCV antibody negative are still at risk of developing PML due to potential for a new JCV infection or a false negative test result
              • Some patients’ serostatus may change intermittently; patients with a negative anti-JCV antibody test result should be retested periodically
              • For purposes of risk assessment, a patient with a positive anti-JCV antibody test at any time is considered anti-JCV antibody positive regardless of results of any prior or subsequent anti-JCV antibody testing; when assessed, anti-JCV antibody status should be determined using an analytically and clinically validated immunoassay
              • After plasma exchange (PLEX), wait at least two weeks to test for anti-JCV antibodies to avoid false-negative test results caused by removal of serum antibodies; after infusion of intravenous immunoglobulin (IVIg), wait at least 6 months (5 half-lives) for the IVIg to clear in order to avoid false positive anti-JCV antibody test results
              • Healthcare professionals should monitor patients on treatment for any new sign or symptom suggestive of PML; symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes
              • The progression of deficits usually leads to death or severe disability over weeks or months; withhold dosing immediately and perform an appropriate diagnostic evaluation at first sign or symptom suggestive of PML
              • MRI findings may be apparent before clinical signs or symptoms; cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported
              • Many patients subsequently became symptomatic with PML; monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present
              • Consider monitoring patients at high risk for PML more frequently; lower PML-related mortality and morbidity have been reported following discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis
              • It is not known whether these differences are due to early detection and discontinuation of therapy or due to differences in disease in these patients
              • There are no known interventions that can reliably prevent PML or that can adequately treat PML if it occurs; PML has been reported following discontinuation of drug in patients who did not have findings suggestive of PML at time of discontinuation; patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for at least six months following discontinuation of treatment
              • There are no known interventions that can reliably prevent PML; PML has been reported following discontinuation of treatment in patients who did not have findings suggestive of PML at time of discontinuation; patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for at least six months following discontinuation of treatment
              • In multiple sclerosis patients, an MRI scan should be obtained prior to initiating therapy; this MRI may be helpful in differentiating subsequent multiple sclerosis symptoms from PM; in Crohn’s disease patients, a baseline brain MRI may also be helpful to distinguish pre-existent lesions from newly developed lesions, but brain lesions at baseline that could cause diagnostic difficulty while on therapy are uncommon
              • For diagnosis of PML, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended; if the initial evaluations for PML are negative but clinical suspicion for PML remains, continue to withhold dosing, and repeat the evaluations
              • There are no known interventions that can adequately treat PML if it occurs; three sessions of PLEX over 5 to 8 days have been shown to accelerate drugclearance in a study of 12 patients with MS who did not have PML, although in the majority of patients, alpha-4 integrin receptor binding remained high
              • Adverse events which may occur during PLEX include clearance of other medications and volume shifts, which have the potential to lead to hypotension or pulmonary edema; although PLEX has not been prospectively studied in treated patients with PML, it has been used in such patients in the postmarketing setting to remove drug more quickly from the circulation
              • There is no evidence that PLEX has any benefit in the treatment of opportunistic infections such as PML
              • JC virus infection of granule cell neurons in the cerebellum (ie, JC virus granule cell neuronopathy [JCV GCN]) reported in patients treated with drug; JCV GCN can occur with or without concomitant PML; JCV GCN can cause cerebellar dysfunction (eg, ataxia, incoordination, apraxia, visual disorders), and neuroimaging can show cerebellar atrophy
              • For diagnosis of JCV GCN, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA, is recommended; JCV GCN should be managed similarly to PML
              • Immune reconstitution inflammatory syndrome (IRIS) has been reported in the majority of treated patients who developed PML and subsequently discontinued therapy; in almost all cases, IRIS occurred after PLEX was used to eliminate circulating drug
              • Immune reconstitution presents as a clinical decline in patient’s condition after drug removal (and in some cases after apparent clinical improvement) that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes in the MRI
              • Therapy has not been associated with IRIS in patients discontinuing treatment for reasons unrelated to PML; in treated patients with PML, IRIS has been reported within days to several weeks after PLEX; monitoring for development of IRIS and appropriate treatment of associated inflammation should be undertaken
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              Pregnancy & Lactation

              Pregnancy

              There are no adequate data on the developmental risk associated with use in pregnant women

              Animal data

              • In animal studies, administration of natalizumab during pregnancy produced fetal immunologic and hematologic effects in monkeys at doses similar to the human dose and reduced offspring survival in guinea pigs at doses greater than the human dose
              • Doses were not maternally toxic but produced the expected pharmacological effects in maternal animals

              Lactation

              Natalizumab has been detected in human milk

              No data available on the effects of this exposure on the breastfed infant or the effects of the drug on milk production

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Recombinant humanized monoclonal antibody that binds to the α4-subunit of α4β1 and α4β7 integrins, prevents leukocyte-endothelial adhesion and leukocyte extravasation

              Absorption

              Peak plasma concentration: 64-132 mcg/mL

              Distribution

              Vd: 5.7 L (multiple sclerosis); 5.2L (Crohn disease)

              Elimination

              Half-Life: 7-15 days (multiple sclerosis); 3-17 days (Crohn disease)

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              Administration

              IV Compatibility

              0.9% NaCl

              IV Incompatibility H3

              No other IV diluents may be used to prepare diluted solution

              IV Preparation

              Concentrate is a colorless opalescent solution

              Visually inspect for particulate matter or discoloration - do not use if either present

              Withdraw 15 mL from the vial and dilute in 100 mL 0.9% NaCl; no other diluent should be used

              Gently invert to mix - do not shake

              Make sure no particulate matter is present

              After dilution, use immediately or within 8 hr (keep refrigerated at 2-8°C)

              If refrigerated, warm before using

              Do not freeze

              IV Administration

              Infuse over 1 hr

              After infusion is complete flush with 0.9% NaCl

              Do not coadminister any other drugs either through Y-site or dissolved in same solution

              Observe patients during infusion and for 1 hr after infusion is complete

              Promptly discontinue infusion upon any signs or symptoms consistent with a hypersensitivity-type reaction

              Use of filtration devices during administration has not been evaluated

              Other medications should not be injected into infusion set side ports or mixed with natalizumab

              Storage

              Unopened vials: Refrigerate at 2-8°C (36-46°F); do not use beyond expiration date on the carton and vial label; do not freeze or shake; protect from light

              Diluted solution: Refrigerate at 2-8°C; use within 8 hr

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              Images

              No images available for this drug.
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              Patient Handout

              Patient Education
              natalizumab intravenous

              NATALIZUMAB - INJECTION

              (NA-ta-LIZ-ue-mab)

              COMMON BRAND NAME(S): Tysabri

              WARNING: Natalizumab increases your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). This risk may be higher the longer you use natalizumab and if you recently used or are currently using other medications that weaken the immune system/increase your risk of infection (such as immunosuppressants, cancer chemotherapy) or other medications that affect the immune system (immunomodulators). Ask your doctor or pharmacist for more information. See also Side Effects and Drug Interactions sections. The risk of PML may also be higher if you have been infected with the virus that causes this infection (JC virus). Your doctor may order a test to see if you have been infected with this virus. Because this medication increases the risk of PML, it is usually used alone and only when other treatments have not worked or you are unable to use them.In the US, natalizumab is only available to patients enrolled in the TOUCH Prescribing Program. In Canada, a similar program is called the Tysabri Care Program. There are two different TOUCH prescribing programs: MS TOUCH for patients with multiple sclerosis, and CD TOUCH for patients with Crohn's disease. Only doctors, infusion centers, and pharmacies enrolled in these programs may prescribe, inject, or provide this medication to patients. Talk with your doctor about the risks and benefits of this medication and other treatment choices. If you and your doctor decide that this is the best treatment for you, your doctor can help you enroll in the TOUCH program. Your doctor will monitor you very closely while you are using this medication, usually at least 3 times during the first year and every 6 months from then on.

              USES: This medication is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.Natalizumab is also used to treat a bowel condition called Crohn's disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels.Natalizumab is a protein called a monoclonal antibody.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using natalizumab and each time you receive another dose. If you have any questions, ask your doctor or pharmacist.This medication is given by a health care professional in an infusion center, usually every 4 weeks or as directed by your doctor. This medication is mixed in a solution and injected slowly into a vein, usually over 1 hour. It should not be given as a rapid injection. You will be monitored for 1 hour after your treatment is finished to make sure you do not have a serious reaction to the medication. (See also Side Effects section.)It is important to use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor's approval.Tell your doctor if your condition worsens. When using this medication for Crohn's disease, if your condition does not improve after 12 weeks of treatment, your doctor will need to switch your treatment plan.

              SIDE EFFECTS: Headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any side effects while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain.Tell your doctor right away if you have any serious side effects, including: severe/persistent headache, stiff/painful neck, fast/pounding heartbeat, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain.This drug increases the risk of a rare, possibly fatal, brain infection (see Warning section for more details). This condition may occur during treatment or, in some cases, after treatment has stopped. In MS patients, the symptoms of PML can seem like an attack of worsening MS. Whether you are using this drug or have stopped using it within the last 6 months, tell your doctor right away of any new or worsening symptoms that have lasted for several days such as: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, problems with speech, vision changes.This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor right away: persistent nausea/vomiting, dark urine, yellowing eyes/skin, feeling tired/weak.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have ever had a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have ever had: a certain virus infection (progressive multifocal leukoencephalopathy-PML).Before using this medication, tell your doctor or pharmacist your medical history, especially of: weakened immune system (such as leukemia, lymphoma, HIV infection, organ transplant), current infections, history of certain virus infections that keep coming back (such as herpes, shingles), mental/mood disorders (such as depression).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: past or current use of other drugs that weaken the immune system/increase the risk of infection (such as azathioprine, cyclosporine, 6-mercaptopurine, methotrexate, fingolimod, TNF blockers such as adalimumab, etanercept, infliximab), long-term use of corticosteroids (such as dexamethasone, prednisone).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Laboratory and/or medical tests (such as MRI, liver function, anti-JCV antibody test) may be performed before you start treatment and repeated periodically to monitor your progress or check for side effects. Consult your doctor for more details.Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Examples of lifestyle changes include stress reduction programs and maintaining a healthy diet. A doctor-approved exercise program may also help MS patients maintain strength, balance, and muscle tone. Consult your doctor or pharmacist for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in an infusion center and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.