CLADRIBINE
Background and Date of Approval
Cladribine is an antineoplastic agent classified as a purine analogue. The FDA approved it in 1993 for the treatment of hairy cell leukaemia.
Uses
It is used to treat Hairy cell leukaemia (cancer of white blood cells). Also, this drug is used in the treatment of Multiple Sclerosis (is a type of autoimmune disorder that affects the nervous system).
How is it administered?
It should only be administered by a trained doctor or nurse experienced in giving chemotherapy. This drug can be administered either as an intravenous (IV) infusion or as a subcutaneous injection. When given as an IV infusion, the drug is administered over a period of two hours. When given as a subcutaneous injection, the drug is administered under the skin using a small needle. Do not self-administer the injection. Your doctor will decide the dose and duration of the treatment based on your disease severity and other factors.
Side Effects
The common side effects that are likely to occur with this medicine are headache, dizziness, eye infection, cough, abnormal breath sounds, nausea, vomiting, abdominal pain, constipation, and diarrhoea. Other serious side effects also include hypersensitivity reactions like itchy skin, rash, swelling of the face and lips, difficulty breathing and cold sweaty skin. Inform your healthcare provider if these side effects concern you or persist for longer than usual.
Warnings
Cladribine is contraindicated in patients who have hypersensitivity reactions. This medicine may cause allergic reactions in some people. Symptoms of an allergic reaction include itching, difficulty breathing, swelling of the face or throat, and a rapid heartbeat. If you experience any of these symptoms, consult your doctor immediately. Also, this drug is contraindicated in patients with current malignancies, active chronic infections like tuberculosis or hepatitis. High doses of this drug have been associated with the irreversible neurologic toxicity (paraparesis/quadriparesis), acute nephrotoxicity, and severe bone marrow suppression resulting in neutropenia, anaemia and thrombocytopenia. Clinicians should also monitor patients frequently for signs and symptoms of neurological impairment, such as numbness or tingling in the arms or legs, weakness, or loss of bowel or bladder control. If these symptoms occur, urgent treatment is necessary to prevent further neurological damage. It is essential to inform your doctor if you have a history of any bleeding disorders, liver or kidney disease, or if you're taking any other medications, including over-the-counter drugs, supplements, or herbal remedies.
Precautions
Consult your doctor before using this medication if you are pregnant or plan to have a baby. This medicine is not recommended for pregnant women as it may cause fetal harm. Your health care practitioner will conduct a pregnancy test before you start treatment with this drug. This medicine may cause birth defects if either partner uses it during conception or pregnancy. Male patients with female partners of reproductive potential should use effective birth control during the treatment and for 3 months after the last dose. Do not breastfeed during the treatment and for 10 days after the last dose. Avoid vaccination with live-attenuated or live vaccines during and after the treatment with this drug while the patientâs white blood cell counts are not within normal limits.
Word of Advice
Avoid contact with people who have infections, particularly while you are taking this medication. Minimise direct skin contact with the tablets, and wash any exposed areas thoroughly. Your doctor will arrange regular blood tests during treatment to monitor blood cell counts and kidney function. Inform your doctor of all other medications you are taking, including over-the-counter drugs, supplements, and herbal remedies.
References
Merck See Ltd, Electronic medicines compendium (emc), [ Revised on Aug 2020], https://www.medicines.org.uk/emc/product/8435/pil [ Accessed on 15th April 2023]. Highlights of prescribing information ... - food and drug administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf [ Accessed on 15th April 2023]. Ema (2022) Mavenclad, European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/mavenclad [ Accessed on 15th April 2023]. SAHPRA Medicines Available at: https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/01/530218_Final_PIL_Mavenclad-10-mg_Applicant.pdf [ Accessed on 15th April 2023]. Cladribine injection warnings - pfizer. Available at: https://cdn.pfizer.com/pfizercom/products/uspi_cladribine.pdf [Accessed on 15th April 2023]. Goodman & Gilmanâs, The Pharmacological Basis of Therapeutics, Cytotoxic agents, 12th edition, 2011, 1703-1704.
Frequently Asked Questions
Who cannot take Cladribine?
Cladribine is primarily eliminated from the body through the kidneys. People with severe kidney impairment may not be able to eliminate the drug effectively, which can increase the risk of side effects. Therefore, those who have kidney disease should talk with your doctor before taking this drug.
What are the warnings of Cladribine?
Patients with severe kidney impairment may not be able to eliminate the drug effectively, which can increase the risk of side effects. Dose adjustments may be necessary for patients with kidney impairment.
Whether Cladribine causes any neurologic events?
Yes, Cladribine can cause neurologic events, such as seizures and neuropathy. Patients should be monitored for signs of neurologic events and inform their healthcare provider if they experience any.
What is the dosing frequency for cladribine?
The recommended dosing of Cladribine is usually 0.09 mg/kg given over a 2-hour intravenous infusion on days 1 and 2 of a 7-day treatment cycle, with cycles repeated every 4 weeks for a total of 6 cycles.
How do you store cladribine?
Cladribine should be stored in a refrigerator at a temperature of 2°C to 8°C. Do not freeze the medication.