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Cyclocel-500 Injection

NAFDAC Reg. No. A4-4987 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Cyclocel-500 Injection
NAFDAC number
A4-4987
Active ingredient
Cyclophosphamide
Strength
500 mg
Form
Powder for injection
Pack size
1 x 1's (in vial)
Manufacturer
Not listed
Applicant (holder)
L'PaceMaker Pharmaceuticals Limited
Approved
24 Jun 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
23 Jun 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Cyclocel-500 Injection is on the NAFDAC register with an active registration (A4-4987). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Cyclocel-500 Injection is used for

From the official U.S. FDA label for cyclophosphamide, the active ingredient registered with NAFDAC.

What it is used for

Cyclophosphamide for injection is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in …

Possible side effects

The following adverse reactions are discussed in more detail in other sections of the labeling. Hypersensitivity [see Contraindications ( 4 )] Myelosuppression, Immunosuppression, Bone Marrow Failure, and Infections [see Warnings and Precautions ( 5.1 )] Urinary Tract and Renal Toxicity [see Warnings and Precautions ( 5.2 )] Cardiotoxicity [see Warnings and Precautions ( 5.3 )] Pulmonary Toxicity [see Warnings and Precautions ( 5.4 )] Secondary Malignancies [see Warnings and Precautions ( 5.5 )] Veno-occlusive Liver Disease [see Warnings and Precautions ( 5.6 )] Infertility [ see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.3 , 8.4 )] Impaired Wound Healing [see Warni …

Do not use if

Hypersensitivity Cyclophosphamide for injection is contraindicated in patients who have a history of severe hypersensitivity reactions to cyclophosphamide, any of its metabolites, or to other components of the product. Anaphylactic reactions including death have been reported with cyclophosphamide. Cross-sensitivity with other alkylating agents can occur. …

Warnings

Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections: Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required. ( 5.1 ) Urinary Tract and Renal Toxicity: Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Urotoxicity can be fatal. Exclude or correct any urinary tract obstructions prior to treatment. ( 5.2 ) Cardiotoxicity: Myocarditis, myopericarditis, pericardial effusion, arrythmias and congestive heart failure, which may be fatal, have been reported. Monitor patients, especially those with risk factors for cardiotoxicity or pre-existing cardiac disease. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )]. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Cyclocel-500 Injection

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Cyclocel-500 Injection

What is in Cyclocel-500 Injection?

Cyclocel-500 Injection contains Cyclophosphamide (500 mg), as powder for injection, according to its NAFDAC registration record.

Is Cyclocel-500 Injection registered with NAFDAC?

Yes. Cyclocel-500 Injection is listed on the NAFDAC register under registration number A4-4987, and its registration is active as of 5 November 2026.

Has Cyclocel-500 Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Cyclocel-500 Injection in our automatically synced alert list.

How can I check that my pack of Cyclocel-500 Injection is genuine?

Run a free authenticity scan with the NAFDAC number A4-4987, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Cyclocel-500 Injection used for?

Cyclophosphamide for injection is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minim (Summarised from the official U.S. FDA label for cyclophosphamide. Always follow your doctor or pharmacist.)

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