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Cladribine

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WARNING

Cladribine may make you more likely to get cancer. If you have cancer or have ever had cancer, let your doctor know. Your doctor might advise against taking cladribine. See your doctor about the best ways to check for cancer symptoms, including self-examinations and screening procedures.

The dangers of cladribine use should be discussed with your physician.

If you are trying to get pregnant or are already pregnant, avoid taking cladribine. Cladribine should be stopped and immediate medical attention should be sought if you become pregnant while taking the medication. There is a chance that cladribine will result in miscarriage or a baby who is born with birth abnormalities (physical problems that are present at birth).

Before starting each round of therapy, your doctor will do an exam to determine whether you are pregnant. During each cycle of cladribine therapy and for at least six months following the last dosage of each therapy, you should take birth control to avoid getting pregnant. During each session of cladribine treatment and for at least 4 weeks following the last dosage of each course of treatment, if you are using hormonal (oestrogen) contraceptives (birth control pills, patches, rings, implants, or injections), you should also use another type of birth control. Use birth control during each cladribine treatment course and for at least six months following the last dosage of each treatment course if you are a male with a female partner who might get pregnant. Discuss birth control options with your doctor so that you can use them both during and after your treatment.

If you need a prescription refill for cladribine, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Why is this medication prescribed?

Cladribine is used to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting forms (a disease course where symptoms occasionally flare up) and active secondary progressive forms (a disease where the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, problems with vision, speech, and bladder control) (course of disease that follows a relapsing-remitting course where symptoms gradually become worse over time). Patients who have already tried one MS medication before turning to cladribine typically do so. Cladribine belongs to a group of drugs known as purine antimetabolites. It functions by preventing specific immune system cells from damaging nerves.

How should this medicine be used?

Cladribine is available as a tablet to be swallowed whole with water. For one treatment cycle, it is typically taken once per day, with or without food, for 4 or 5 days straight. To finish one treatment session, repeat the second treatment cycle 23–27 days later. At least 43 weeks must pass after the final dose of the second cycle for the second course (2 treatment cycles) to be administered. Take cladribine every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Pursue cladribine dosage as prescribed. Never take it in larger or less amounts or more frequently than recommended by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Using dry hands, remove the tablet from the blister pack, and immediately swallow it. Keep the tablet off of your skin for as little time as possible. Don’t touch your eyes, nose, or other body parts. Wash your hands thoroughly with water after taking the drug. Wash any surfaces or any areas of your body that the tablet may have touched thoroughly with water right away.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking cladribine,

  • If you have an allergy to cladribine, any other drugs, or any of the substances in cladribine tablets, inform your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you are taking any other oral drugs, take them three hours prior to or three hours following the cladribine.
  • Inform your physician about all herbal or over-the-counter medications you are taking, including curcumin and St. John’s wort. When beginning to take cladribine, be careful to let your doctor and pharmacist know that you are taking these medications. While taking cladribine, do not begin taking any of these medications without first consulting your doctor.
  • Inform your doctor if you have any active infections, including the human immunodeficiency virus (HIV), hepatitis (a virus that affects the liver and may cause severe liver damage), tuberculosis (TB), which is a deadly infection that affects the lungs and occasionally other parts of the body. Most likely, your doctor will advise against taking cladribine.
  • Inform your doctor if you have or have ever had liver, renal, or heart illness as well as herpes zoster (shingles; a rash that can develop in people who have previously had chickenpox). Moreover, let your doctor know if you’ve never had chickenpox and haven’t received a vaccination against the disease. Before or during your treatment with cladribine, your doctor could advise getting the chickenpox or shingles vaccine.
  • Inform your doctor if you are nursing a baby. Throughout a treatment cycle and for 10 days following the last dosage of the cycle, you shouldn’t breastfeed.
  • You should let your doctor or dentist know that you are taking cladribine if you are having surgery, including dental surgery.
  • Without consulting your doctor, avoid getting any shots within the 4 to 6 weeks leading up to, during, or following your treatment with cladribine. Before starting your therapy, ask your doctor if you need to get any vaccines.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

On the same day, take the missed dose as soon as you remember. The missing dose should be taken the next day to extend the treatment cycle if it is not taken on the planned day. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects from cladribine are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Nausea
  • Back ache
  • Painful and stiff joints
  • Having trouble falling or staying asleep
  • Depression
  • Hair fall
  • Sores on the lips, gums, or mouth that are tingly, itchy, or burning

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if you have any of these symptoms:

  • Infection symptoms such as a fever, sore throat, chills, hurting or uncomfortable muscles, cough, or other symptoms
  • Chest pain, a cough that produces blood or mucus, fatigue or weakness, appetite loss or loss of weight, chills, fever, or night sweats
  • Blistered rash that hurts
  • Itching, tingling, burning, or numbness on the skin
  • Rash, breathing or swallowing issues, face, lip, tongue, or throat swelling or itching
  • Chills, a fever, nausea, vomiting, back, side, or groyne discomfort, as well as painful and frequent urine
  • Uncommon bruising or bleeding
  • Weakness on one side of your body, changes in your vision, thinking, memory, or personality, loss of coordination in your arms or legs, diminished strength, balance issues, or confusion
  • Breathing difficulty, rapid heartbeat, headache, wooziness, pale skin, disorientation, and exhaustion
  • Dark urine, tremendous fatigue, stomach discomfort in the upper right part, acute nausea, vomiting, and extreme exhaustion
  • Breathing difficulty, an erratic or rapid heartbeat, and body swelling

Further negative effects of cladribine may occur. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Be on time for all appointments with your doctor and the lab. Before, during, and after your treatment, your doctor will order specific tests to determine whether it is safe for you to take cladribine and to monitor your body’s reaction to cladribine.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Mavenclad®
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