Cladrim 10 Injection
Brand Name: Cladrim 10 Injection
International Trade Name: Leustatin
Active Substance: Cladribine
Strength: 10mg
Category: Anti-Cancer
Manufacturer: Fresenius Kabi India Pvt Ltd
Pack: 1 Vial
Product Form: Injection
Description of Cladrim 10 (Cladribine 10 mg) injection
Cladribine, a constituent of Cladrim 10 injection is an antineoplastic agent which is of the purine analog antimetabolite group. It is predominantly applied in the management of some hematological malignancies especially the hairy cell leukemia. Cladribine is structurally related with adenosine and it has a mode of action of interfering with the DNA synthesis and repair.
Once in the cell, Cladribine is phosphorylated into its active form and this is built up in the lymphocytes as a result of low degrading enzyme levels. This causes an interruption in the process of DNA synthesis, strand breaks and subsequent apoptosis of the cancer cells. It is particularly toxic to lymphocytes and is therefore very effective in lymphoid malignancies.
Indications of Cladrim 10 (Cladribine 10 mg) injection
Cladribine has been used in hairy cell leukemia, and may be used in other lymphoid malignancies and multiple sclerosis (when orally).
Mechanism of action of Cladrim 10 (Cladribine 10 mg) injection
Cladribine is transformed into its active triphosphate form on the inside of cells. It is integrated into DNA and blocks DNA polymerase and ribonucleotide reductase causing DNA strand breaks and preventing DNA synthesis. It is toxic to dividing and non-dividing lymphocytes leading to prolonged lymphocyte depletion.
How to consume Cladrim 10 (Cladribine 10 mg) injection
Cladribine is used as an intravenous drug. The dosage is calculated on the basis of body weight and most of the time, it is in the form of a continuous infusion over days depending on the treatment regime.
Side Effects of Cladrim 10 (Cladribine 10 mg) injection
- Common Side Effects
- Fever
- Fatigue
- Nausea
- Headache
- Serious Side Effects
- Severe bone marrow suppression
- Infections
- Neurotoxicity
- Rare Side Effects
- Secondary malignancies
- Hypersensitivity reactions
Safety Advice for Cladrim 10 (Cladribine 10 mg) injection
Cladribine patients are vulnerable to immune function and blood counts as there is severe lymphocyte suppression.
Breastfeeding: Not advisable, because there is a possibility of the drug transferring to breast milk and causing harm to the baby.
Pregnancy: Contraindicated because of the risk of inflictting harm on the fetus.
Alcohol: This should be avoided since it can increase fatigue and stress on the liver.
Liver: No hepatic metabolism is predominant but liver activity should be observed.
Lungs: Check on infections particularly opportunistic infections of lungs.
Kidney: In renal impairment the dose can be decreased.
Driving: Patients can be dizzy or tired, not to drive when they are not feeling better.
Interaction of Cladrim 10 (Cladribine 10 mg) injection
- Drug–Drug Interaction
Other immunosuppressive drugs × Cladribine
May can cause a lot of risk of infections as there is additive immunosuppression.
Live vaccines × Cladribine
Contraindicated because an immunosuppressed organism is more likely to have an infection secondary to vaccination.
Cytotoxic drugs × Cladribine
May augment bone marrow oppression and toxicity.
- Drug–Food Interaction
None of the key food interactions (parenteral drug). Be well hydrated and nourished.
- Drug–Disease Interaction of Cladrim 10 (Cladribine 10 mg) injection
Bone marrow disorders:
Cladribine brings about severe myelosuppression, which aggravates underlying diseases.
Infections:
Immunosuppression is very dangerous to patients who have infections and may lead to worsening.
Renal impairment:
Low clearance can cause toxicity and accumulation of drugs.
Neurological disorders:
Patients with underlying neurological conditions may have a more intense neurotoxicity.
Contraindication of Cladrim 10 (Cladribine 10 mg) injection
Should not be used in hypersensitivity, acute infections and pregnancy.
Dosage of Cladrim 10 (Cladribine 10 mg) injection
Continuous infusion according to protocol based on body weight.
Storage of Cladrim 10 (Cladribine 10 mg) injection
Keep in desired conditions out of the sunlight.
Missed Dose of Cladrim 10 (Cladribine 10 mg) injection
Give under medical supervision.
Other General Information of Cladrim 10 (Cladribine 10 mg) injection
Follow-ups should be done regularly to patients. The symptoms like fever, infections or neurological changes should be reported as early as possible.
FAQs of Cladrim 10 (Cladribine 10 mg) injection
- What is the reason why Cladribine is very effective in lymphoid cancers?
Since it is stored in lymphocytes and leads to long-lasting depletion of the lymphocytes.
- What makes it lead to long-term immunosuppression?
As a result of a prolonged loss of T and B lymphocytes.
- What is the reason why infections are common?
Due to the drastically lower functioning of the immune system.
- Does Cladribine have any impact to the brain?
Yes, with large doses, there can be neurotoxicity.
- What is the purpose of monitoring?
To identify the early bone marrow suppression and infection.
Fact Box of Cladrim 10 (Cladribine 10 mg) injection
| Field | Details |
| Generic Name | Cladribine |
| Therapeutic Class | Anti-neoplastic agent |
| Pharmacological Class | Antimetabolite (Purine analog) |
| Dosage form | Injection |
| Habit forming | No |
| Indication | Hairy cell leukemia |
References
- FDA Prescribing Information – Cladribine
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020305s020lbl.pdf - European Medicines Agency (EMA) – Cladribine Product Information
https://www.ema.europa.eu/en/documents/product-information/Cladrim-epar-product-information_en.pdf - DrugBank – Cladribine
https://go.drugbank.com/drugs/DB00242 - National Cancer Institute (NCI) – Cladribine
https://www.cancer.gov/about-cancer/treatment/drugs/cladribine






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