CLADRIBINE INJECTION
As listed in the register: CLADRIBINE INJECTION
1 mg · solution
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Cladribine
- Made by
- Fresenius Kabi Canada Ltd
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Cladribine). It describes the substance, not this exact product.
The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes.
After administration of 10 mg oral cladribine in MS patients, 28.5 [20] (mean [SD]) percent of the dose was excreted unchanged via the renal route.
Effect of Food Following administration of cladribine with a high fat meal, the geometric mean C max decreased by 29% and AUC was unchanged.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-19
Safety of the active substance
From the US prescribing label for the same active substance (Cladribine). It describes the substance, not this exact product.
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY WARNING: MALIGNANCIES and RISK OF TERATOGENICITY See full prescribing information for complete boxed warning.
- Cladribine is contraindicated: in patients with current malignancy [see Warnings and Precautions (5.1) ]. in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course for females and 14 weeks for males.
- Patients with current malignancy.
- ( 4 ) Pregnant women, and females and males of reproductive potential who do not plan to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course for females and 14 weeks for males.
- ( 4, 8.3 ) HIV infection.
The most common (> 20%) adverse reactions reported in Study 1 are upper respiratory tract infection, headache, and lymphopenia.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Fresenius Kabi Canada Ltd |
|---|---|
| Active substance | Cladribine |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 1 mg |
| Form | solution |
| Classification | L01BB04 · Cancer treatments and immune-system medicines |
| Route | intravenous |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02319918 |
| DPD drug code | 80536 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution2 products
1 mg2
1 mg · 2 companies
- Fresenius Kabi Canada Ltd · this page
- Generic Medical Partners Inc
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.