Mavenclad 10mg Tabs (6) Pak
WARNING: This drug may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor.This drug may raise the risk of cancer. Do not take this drug to treat MS if you have cancer. If you have a risk for cancer or have ever had cancer, talk with your doctor.This drug may cause harm to the unborn baby if you take it while pregnant. Do not take this drug if you are pregnant, or if you are able to get pregnant but are not using birth control.If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this drug. Talk with your doctor.If you or your sex partner may become pregnant, you must use birth control while taking this drug and for 6 months after the last dose. Ask your doctor how long to use birth control and what kind of birth control to use. If you or your sex partner gets pregnant while taking this drug or within 6 months after stopping it, call the doctor right away. @ COMMON USES: It is used to treat MS (multiple sclerosis).
Drug Class
Disease-modifying therapy (DMT) for Multiple Sclerosis
Pharmacologic Class
Purine antimetabolite; Selective immunosuppressant
Pregnancy Category
X
FDA Approved
Mar 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mavenclad is a medication used to treat a type of multiple sclerosis (MS) called relapsing-remitting MS. It works by reducing the number of certain white blood cells (lymphocytes) that are involved in the immune system's attack on the brain and spinal cord in MS. It's given in short courses over two years, and its effects can last for a long time.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Swallow the tablet whole with a glass of water. Do not chew the tablet.
If you take other oral medications, take them at least 3 hours before or 3 hours after taking this medication. If this is not possible, consult your doctor.
Handling Your Medication
When handling your medication, take special precautions:
Consult your doctor or pharmacist for guidance on how to handle your medication safely.
Do not remove the medication from its blister pack until you are ready to take it.
Take the medication immediately after opening the blister pack. Do not store the removed medication for later use.
Make sure your hands are dry before touching the medication.
Wash your hands after handling the medication.
Storing and Disposing of Your Medication
To store your medication properly:
Keep it in its original container at room temperature.
Store it in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember on the same day.
If you don't remember until the next day, take the missed dose and then take your next dose the day after.
Your treatment schedule will be extended by one day.
* Do not take two doses at the same time or take extra doses.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Swallow the tablet whole with a glass of water. Do not chew the tablet.
If you take other oral medications, take them at least 3 hours before or 3 hours after taking this medication. If this is not possible, consult your doctor.
Handling Your Medication
When handling your medication, take special precautions:
Consult your doctor or pharmacist for guidance on how to handle your medication safely.
Do not remove the medication from its blister pack until you are ready to take it.
Take the medication immediately after opening the blister pack. Do not store the removed medication for later use.
Make sure your hands are dry before touching the medication.
Wash your hands after handling the medication.
Storing and Disposing of Your Medication
To store your medication properly:
Keep it in its original container at room temperature.
Store it in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember on the same day.
If you don't remember until the next day, take the missed dose and then take your next dose the day after.
Your treatment schedule will be extended by one day.
* Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid live or live-attenuated vaccines during and after treatment until lymphocyte counts recover (typically 4-6 weeks after the last dose of each annual course).
- Report any signs of infection (fever, chills, sore throat, unusual fatigue) immediately to your doctor.
- Report any new or worsening lumps, unexplained weight loss, or other unusual symptoms to your doctor.
- Use effective contraception during treatment and for at least 6 months after the last dose for both males and females.
- Avoid pregnancy during treatment and for 6 months after the last dose.
- Do not breastfeed during treatment and for 10 days after the last dose.
- Stay hydrated and maintain good hygiene to reduce infection risk.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
3.5 mg/kg cumulative dose over 2 years, administered as 1.75 mg/kg per year. Each annual dose is divided into 2 treatment courses (e.g., 10 mg or 20 mg tablets daily for 4-5 consecutive days in Month 1, and again in Month 2).
Condition-Specific Dosing:
Multiple Sclerosis:
Cumulative dose of 3.5 mg/kg (actual body weight) administered orally over 2 years. Each annual treatment course (1.75 mg/kg) is given as two treatment weeks, one at the beginning of Month 1 and one at the beginning of Month 2 of the respective treatment year. Each treatment week consists of 4 or 5 days of daily dosing (10 mg or 20 mg) depending on body weight.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl 60-89 mL/min)
Moderate:
Contraindicated (CrCl 30-59 mL/min)
Severe:
Contraindicated (CrCl <30 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No dose adjustment required
Moderate:
No dose adjustment required
Severe:
No dose adjustment required, but caution is advised due to limited data.
Pharmacology
Mechanism of Action
Cladribine is a purine nucleoside analog. It is a prodrug that is phosphorylated intracellularly by deoxycytidine kinase (DCK) to its active triphosphate form, cladribine triphosphate (Cd-ATP). Lymphocytes, particularly B and T cells, have high levels of DCK and low levels of 5'-nucleotidase (which dephosphorylates Cd-ATP), leading to selective accumulation of Cd-ATP in these cells. Cd-ATP interferes with DNA synthesis and repair, leading to DNA strand breaks, inhibition of DNA polymerase, and ultimately apoptosis of dividing and non-dividing lymphocytes. This results in a sustained reduction in lymphocyte counts, particularly CD4+ and CD8+ T cells and CD19+ B cells, which are implicated in the pathogenesis of MS.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40%
Tmax:
Approximately 0.5 hours (range 0.5-1.5 hours)
FoodEffect:
Food does not significantly affect bioavailability.
Distribution:
Vd:
Approximately 490-980 L (high volume of distribution)
ProteinBinding:
Approximately 20%
CnssPenetration:
Limited (CSF concentrations are approximately 25% of plasma concentrations)
Elimination:
HalfLife:
Approximately 24 hours (terminal half-life of cladribine in plasma); intracellular half-life of Cd-ATP is much longer (e.g., 15 hours in lymphocytes)
Clearance:
Approximately 22-24 L/hr (renal and non-renal)
ExcretionRoute:
Renal (approximately 50% of dose excreted unchanged in urine)
Unchanged:
Approximately 50%
Pharmacodynamics
OnsetOfAction:
Lymphocyte count reduction begins within days to weeks of first dose.
PeakEffect:
Maximum lymphocyte reduction typically occurs 2-3 months after each annual treatment course.
DurationOfAction:
Immunological effects (lymphocyte reduction) are sustained for at least 2 years after the last dose of the 2-year treatment regimen. Clinical efficacy is observed over the 2-year treatment period and beyond.
Safety & Warnings
BLACK BOX WARNING
MALIGNANCY: MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with active malignancy. Evaluate patients for malignancy prior to and during treatment. LYMPHOPENIA: MAVENCLAD causes dose-dependent reductions in lymphocyte counts. MAVENCLAD is contraindicated in patients with active chronic infections (e.g., hepatitis, tuberculosis) or with a history of human immunodeficiency virus (HIV) infection. Obtain a complete blood count (CBC) with differential, including lymphocyte count, before initiation of MAVENCLAD in Year 1 and Year 2, and at Month 2 and Month 6 of each treatment year. If lymphocyte counts are below 500 cells/mm³, monitor patients closely for infections and consider delaying or discontinuing MAVENCLAD.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Shingles: Pain, itching, or tingling, fever, muscle aches, or a rash (with or without blisters).
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Other Severe Symptoms: Extreme fatigue or weakness, shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Abnormal or rapid heartbeat, signs of high blood pressure (severe headache, dizziness, fainting, or changes in vision).
Depression: Mood changes or feelings of sadness.
Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain condition that can cause disability or be life-threatening. Seek medical help if you experience confusion, memory problems, depression, changes in behavior, uneven strength, speech or thinking difficulties, balance problems, or vision changes.
Liver Problems: Sometimes life-threatening, liver issues can cause dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes. Contact your doctor immediately if you experience any of these symptoms.
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Sleep disturbances
* Hair thinning or loss
This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Shingles: Pain, itching, or tingling, fever, muscle aches, or a rash (with or without blisters).
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Other Severe Symptoms: Extreme fatigue or weakness, shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Abnormal or rapid heartbeat, signs of high blood pressure (severe headache, dizziness, fainting, or changes in vision).
Depression: Mood changes or feelings of sadness.
Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain condition that can cause disability or be life-threatening. Seek medical help if you experience confusion, memory problems, depression, changes in behavior, uneven strength, speech or thinking difficulties, balance problems, or vision changes.
Liver Problems: Sometimes life-threatening, liver issues can cause dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes. Contact your doctor immediately if you experience any of these symptoms.
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Common cold symptoms
Upset stomach
Headache
Back pain
Joint pain
Sleep disturbances
* Hair thinning or loss
This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of infection: fever, chills, body aches, sore throat, cough, painful urination, skin rash, unusual fatigue.
- Signs of malignancy: new or growing lumps, unexplained weight loss, persistent cough, changes in moles, unusual bleeding.
- Signs of Progressive Multifocal Leukoencephalopathy (PML): new or worsening weakness on one side of the body, clumsiness, vision changes, changes in thinking or memory, personality changes.
- Severe allergic reactions: rash, itching, swelling of the face/tongue/throat, severe dizziness, trouble breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Existing health conditions, including kidney disease or liver disease.
Infections such as hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, and infections may be contraindicated.
A diagnosis of clinically isolated syndrome (CIS).
If you are breast-feeding or plan to breast-feed. Note that breast-feeding is not recommended while taking this medication, and you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary duration.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Existing health conditions, including kidney disease or liver disease.
Infections such as hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, and infections may be contraindicated.
A diagnosis of clinically isolated syndrome (CIS).
If you are breast-feeding or plan to breast-feed. Note that breast-feeding is not recommended while taking this medication, and you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary duration.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be at a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, this medication may increase your tendency to bleed easily. To reduce the risk of injury, exercise caution in your daily activities and use a soft toothbrush and an electric razor for personal grooming.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. If you are not up to date with all recommended vaccinations, consult your doctor to determine if any vaccines are necessary before starting treatment with this drug.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may need to order an MRI scan before initiating treatment.
There is a risk of developing herpes zoster (shingles) while taking this medication. Consult your doctor to determine if vaccination against shingles is recommended before starting treatment.
Furthermore, cases of hepatitis and tuberculosis (TB) have been reported in patients taking this drug, and in some instances, these infections have been fatal. To assess your risk, you will undergo testing for hepatitis and TB before the first and second treatment courses.
While taking this drug, you may be at a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, this medication may increase your tendency to bleed easily. To reduce the risk of injury, exercise caution in your daily activities and use a soft toothbrush and an electric razor for personal grooming.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. If you are not up to date with all recommended vaccinations, consult your doctor to determine if any vaccines are necessary before starting treatment with this drug.
Before receiving any vaccinations, discuss the potential risks and benefits with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may need to order an MRI scan before initiating treatment.
There is a risk of developing herpes zoster (shingles) while taking this medication. Consult your doctor to determine if vaccination against shingles is recommended before starting treatment.
Furthermore, cases of hepatitis and tuberculosis (TB) have been reported in patients taking this drug, and in some instances, these infections have been fatal. To assess your risk, you will undergo testing for hepatitis and TB before the first and second treatment courses.
Overdose Information
Overdose Symptoms:
- Severe lymphopenia
- Myelosuppression (anemia, thrombocytopenia, neutropenia)
- Neurological toxicity (ataxia, weakness, sensory deficits)
What to Do:
There is no specific antidote. Treatment is supportive. Discontinue cladribine. Monitor hematologic parameters closely and manage complications such as infection or bleeding. Consider blood transfusions or growth factors as needed. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine) - due to additive immunosuppressive effects and risk of severe myelosuppression.
- Live or live-attenuated vaccines - due to risk of vaccine-induced infection (should not be administered during and after cladribine treatment until lymphocyte counts recover).
Major Interactions
- Other myelosuppressive agents (e.g., carbamazepine, chloramphenicol, co-trimoxazole) - increased risk of hematologic toxicity.
- Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs) - caution, though direct interaction is not primary concern, renal impairment is a contraindication for cladribine.
Moderate Interactions
- Drugs that affect lymphocyte counts (e.g., corticosteroids, interferon beta) - potential additive effects on lymphocyte reduction.
- P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, verapamil, ritonavir) - may increase cladribine exposure (cladribine is a P-gp substrate).
- P-glycoprotein (P-gp) inducers (e.g., rifampin, St. John's Wort) - may decrease cladribine exposure.
Minor Interactions
- Nucleoside transport inhibitors (e.g., dilazep, nifedipine, nimodipine, reserpine, diltiazem) - theoretical potential to alter cladribine cellular uptake, but clinical significance is unknown.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential (especially lymphocyte count)
Rationale: To ensure baseline lymphocyte count is within normal limits and to identify any pre-existing cytopenias. Lymphocyte count must be ≥ 800 cells/mm³.
Timing: Within 10 days prior to the first dose of each annual treatment course.
Varicella Zoster Virus (VZV) serology
Rationale: To assess immunity to VZV. Vaccination should be considered for VZV-seronegative patients prior to treatment.
Timing: Prior to initiating treatment.
Tuberculosis (TB) screening
Rationale: To rule out active or latent TB infection, as cladribine can reactivate latent infections.
Timing: Prior to initiating treatment.
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiating treatment.
Renal function tests (e.g., serum creatinine, eGFR)
Rationale: To assess baseline renal function, as severe renal impairment is a contraindication.
Timing: Prior to initiating treatment.
MRI of the brain
Rationale: To establish baseline disease activity and rule out other conditions.
Timing: Prior to initiating treatment.
Screening for malignancy
Rationale: Cladribine is associated with an increased risk of malignancy.
Timing: Prior to initiating treatment and as clinically indicated.
Routine Monitoring
Complete Blood Count (CBC) with differential (especially lymphocyte count)
Frequency: Before each treatment course (Month 1 and Month 2 of each year), and at Month 3 and Month 6 after the start of each annual treatment course. More frequently if clinically indicated.
Target: Lymphocyte count should be ≥ 800 cells/mm³ before starting a treatment course.
Action Threshold: If lymphocyte count is < 500 cells/mm³ at Month 3 or 6, or if severe lymphopenia (Grade 4, < 200 cells/mm³) occurs, treatment may be delayed or discontinued. If lymphocyte count is < 800 cells/mm³ before a treatment course, delay until recovery.
Signs and symptoms of infection
Frequency: Regularly throughout treatment and follow-up.
Target: N/A
Action Threshold: Prompt evaluation and management of any suspected infection.
Signs and symptoms of malignancy
Frequency: Regularly throughout treatment and follow-up.
Target: N/A
Action Threshold: Prompt evaluation of any suspected malignancy.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat, unusual fatigue, skin lesions)
- Signs of malignancy (new or worsening lumps, unexplained weight loss, persistent cough, changes in bowel/bladder habits)
- Progressive Multifocal Leukoencephalopathy (PML) symptoms (new or worsening neurological symptoms like weakness, vision changes, cognitive impairment)
Special Patient Groups
Pregnancy
Contraindicated. Cladribine is highly teratogenic and can cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. Males with partners of childbearing potential must also use effective contraception during treatment and for at least 6 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and fetal death due to cladribine's mechanism of action (DNA synthesis interference).
Second Trimester:
High risk of fetal harm, including growth restriction and hematologic abnormalities.
Third Trimester:
High risk of fetal harm, including hematologic abnormalities and potential for premature birth.
Lactation
Contraindicated. Cladribine is excreted in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment and for 10 days after the last dose of each treatment course.
Infant Risk:
L5 (Contraindicated - significant risk to infant)
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Not recommended for use in this population.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution in elderly patients, considering the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. No specific dose adjustment is recommended based on age alone.
Clinical Information
Clinical Pearls
- Mavenclad is a high-efficacy DMT for MS, administered in two short annual courses over two years, with effects lasting beyond the treatment period.
- Strict adherence to lymphocyte monitoring is crucial due to the risk of severe lymphopenia and associated infections.
- Patients must be screened for active infections (including VZV and TB) and malignancy before initiation.
- Live vaccines are contraindicated during and after treatment until lymphocyte counts recover.
- Effective contraception is mandatory for both male and female patients during and for 6 months after the last dose due to teratogenicity.
- Patients should be educated on signs of infection and malignancy and instructed to report them immediately.
Alternative Therapies
- Interferon beta (e.g., Avonex, Betaseron, Rebif, Plegridy)
- Glatiramer acetate (e.g., Copaxone, Glatopa)
- Natalizumab (Tysabri)
- Fingolimod (Gilenya)
- Dimethyl fumarate (Tecfidera)
- Teriflunomide (Aubagio)
- Ocrelizumab (Ocrevus)
- Alemtuzumab (Lemtrada)
- Siponimod (Mayzent)
- Ozanimod (Zeposia)
- Ponesimod (Ponvory)
Cost & Coverage
Average Cost:
Varies widely, typically >$80,000 per year of treatment per annual treatment course
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.