Mavenclad 10mg Tabs (8) Pak
Overview
What is this medicine?
How to Use This Medicine
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this 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 this medication. If this is not possible, consult your doctor for guidance.
Handling Your Medication
You will need to take special precautions when handling this medication. Consult your doctor or pharmacist for instructions on how to handle it safely. Only remove the medication from the blister pack when you are ready to take it, and take it immediately after opening the pack. Do not store the removed medication for future use. Make sure your hands are dry before touching the medication, and wash your hands after handling it.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature in a dry place. Avoid storing it in a 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, take it 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. This will extend your treatment week 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 your doctor says it's safe (usually when lymphocyte counts recover).
- Practice good hygiene (frequent hand washing) to reduce infection risk.
- Report any signs of infection (fever, chills, rash, sore throat) immediately.
- Report any new or changing skin lesions or other signs of cancer.
- Use effective contraception during treatment and for at least 6 months after the last dose for both males and females.
- Discuss any planned pregnancies with your doctor well in advance.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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 discolored sputum, 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 bruises that enlarge, 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.
Extreme Fatigue or Weakness: Feeling very tired or weak.
Respiratory Problems: Shortness of breath, significant weight gain, or swelling in the arms or legs.
Cardiac Issues: Rapid or abnormal heartbeat.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Depression: Mood changes or feelings of sadness.
Progressive Multifocal Leukoencephalopathy (PML): A rare and potentially fatal brain condition. Seek immediate medical attention 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 may cause dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes. Contact your doctor right away if you notice 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, painful skin rash (especially blistering), cough, burning urination.
- Signs of malignancy: unexplained weight loss, persistent fatigue, new or changing moles/skin lesions, persistent cough, unexplained bleeding.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
- Signs of PML: new or worsening weakness on one side of your body, clumsiness, vision changes, changes in thinking or memory, confusion, personality changes.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Existing health conditions, such as kidney disease or liver disease.
Infections like hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
Any prescription or over-the-counter medications, natural products, or vitamins you are taking, as some may interact with this medication. Specifically, certain drugs used to treat hepatitis C, HIV, infections, and other conditions should not be taken with this medication.
A diagnosis of clinically isolated syndrome (CIS).
If you are breast-feeding, as you should not breast-feed while taking this medication. Your doctor will advise you on whether to avoid breast-feeding for a period after your last dose.
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 start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
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 likelihood of bleeding 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 with your doctor, as you may need to receive certain vaccines before starting treatment with this drug.
Before receiving any vaccinations during treatment, discuss the potential risks and benefits with your doctor, as some vaccines may increase the risk of infection or reduce their effectiveness when used in conjunction with this medication.
If you have taken this drug and are scheduled to receive a blood transfusion, inform your doctor, as they may order an MRI scan before initiating treatment.
There is a risk of developing herpes zoster (shingles) while taking this medication. Consult with your doctor to determine if a vaccine is necessary before starting treatment.
Furthermore, cases of hepatitis and tuberculosis (TB) have been reported in patients taking this drug, and in some instances, these conditions have been fatal. As a precautionary measure, you will undergo testing for hepatitis and TB before the first and second treatment courses to assess your risk and take appropriate preventive measures.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (very low white blood cell counts, red blood cell counts, and platelet counts)
- Severe lymphopenia
- Increased risk of infection
What to Do:
There is no specific antidote for cladribine overdose. Management involves careful monitoring of blood counts and supportive care, including transfusions if necessary, and appropriate anti-infective therapy if infections occur. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine) - due to additive immunosuppressive effects and risk of myelosuppression.
- Chronic concomitant use of myelosuppressive agents (e.g., carbamazepine, zidovudine) - due to additive myelosuppressive effects.
Major Interactions
- Live or live-attenuated vaccines - risk of vaccine-induced infection (should not be administered during and after cladribine treatment until lymphocyte counts recover).
- Other disease-modifying therapies for MS (e.g., interferon beta, glatiramer acetate, natalizumab, fingolimod, ocrelizumab, teriflunomide, dimethyl fumarate) - due to potential for additive immunosuppression; a washout period may be required.
- Drugs that affect lymphocyte counts (e.g., corticosteroids, other immunosuppressants) - potential for additive effects on lymphocyte counts.
Moderate Interactions
- Strong BCRP (Breast Cancer Resistance Protein) inhibitors (e.g., eltrombopag, cyclosporine, gefitinib, lapatinib, ritonavir) - may increase cladribine exposure. Use with caution.
- Strong BCRP inducers (e.g., rifampin, St. John's Wort) - may decrease cladribine exposure. Use with caution.
- Nucleoside transport inhibitors (e.g., dilazep, nifedipine, nimodipine, reserpine, verapamil) - may alter cladribine cellular uptake and efficacy/toxicity. Use with caution.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline lymphocyte count and identify pre-existing lymphopenia, which is a contraindication or requires careful consideration.
Timing: Within 10 days prior to the first dose of each treatment course (Year 1 and Year 2).
Rationale: To rule out active or latent TB infection, as cladribine can reactivate latent infections.
Timing: Prior to initiation of Mavenclad.
Rationale: To rule out active infection, as cladribine can reactivate viral infections.
Timing: Prior to initiation of Mavenclad.
Rationale: To assess immunity; vaccination should be considered for seronegative patients prior to treatment.
Timing: Prior to initiation of Mavenclad.
Rationale: To establish baseline liver function and identify pre-existing hepatic impairment.
Timing: Prior to initiation of Mavenclad.
Rationale: To ensure patient is not pregnant, as cladribine is contraindicated in pregnancy.
Timing: Prior to initiation of Mavenclad in females of reproductive potential.
Routine Monitoring
Frequency: Before each treatment course (Year 1 and Year 2), and at Months 2 and 6 of Year 1 and Year 2. More frequently if clinically indicated.
Target: Lymphocyte count should be ≥ 800 cells/mm³ before starting each treatment course. If <800 cells/mm³, delay treatment.
Action Threshold: If lymphocyte count is <500 cells/mm³ at Month 2 or 6, monitor closely until recovery. If <200 cells/mm³, consider prophylactic antiviral therapy for herpes zoster.
Frequency: Regularly throughout treatment and follow-up.
Target: N/A
Action Threshold: Prompt evaluation and treatment of any suspected infection.
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, painful rash, cough, dysuria)
- Signs of malignancy (unexplained weight loss, persistent fatigue, new or changing moles/skin lesions, persistent cough, unexplained bleeding)
- Signs of liver injury (jaundice, dark urine, abdominal pain, nausea, vomiting)
- Signs of progressive multifocal leukoencephalopathy (PML) (new or worsening neurological symptoms, cognitive changes, visual disturbances, weakness, speech difficulties)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women and women of reproductive potential not using effective contraception. Cladribine can cause fetal harm. Women of childbearing potential must use effective contraception during cladribine treatment and for at least 6 months after the last dose. Men must use effective contraception during cladribine treatment and for at least 6 months after the last dose.
Trimester-Specific Risks:
Lactation
Contraindicated. Cladribine is excreted in human milk and has the potential for serious adverse reactions in breastfed infants. Women should not breastfeed during cladribine treatment and for at least 10 days after the last dose.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients under 18 years of age.
Geriatric Use
Clinical studies of Mavenclad did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Use with caution, generally no specific dose adjustment is needed based on age alone, but consider age-related decline in renal function and increased susceptibility to infections.
Clinical Information
Clinical Pearls
- Mavenclad is a high-efficacy MS therapy with a unique short-course oral dosing regimen over two years, providing sustained benefit for up to four years without continuous daily dosing.
- Strict adherence to the monitoring schedule for lymphocyte counts is crucial due to the risk of severe lymphopenia and associated infections.
- Patients must be screened for active infections (TB, hepatitis, HIV) and malignancy prior to initiation.
- Vaccination with live or live-attenuated vaccines should be avoided during and after treatment until lymphocyte counts recover.
- Counsel patients extensively on contraception requirements for both males and females due to teratogenicity and genotoxicity concerns.
- The risk of malignancy is a significant concern; regular cancer screening should be emphasized.
- Herpes zoster reactivation is a common infection; consider antiviral prophylaxis for severe lymphopenia.
Alternative Therapies
- Interferon beta (e.g., Avonex, Betaseron, Rebif, Plegridy)
- Glatiramer acetate (e.g., Copaxone, Glatopa)
- Fingolimod (Gilenya)
- Natalizumab (Tysabri)
- Ocrelizumab (Ocrevus)
- Alemtuzumab (Lemtrada)
- Dimethyl fumarate (Tecfidera)
- Teriflunomide (Aubagio)
- Siponimod (Mayzent)
- Ozanimod (Zeposia)
- Ponesimod (Ponvory)
- Diroximel fumarate (Vumerity)