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Jevtana Concentrate For Solution for Infusion

NAFDAC Reg. No. A4-100070 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Jevtana Concentrate For Solution for Infusion
NAFDAC number
A4-100070
Active ingredient
Cabazitaxel
Strength
60 mg/1.5 mL
Form
Concentrate for solution for infusion
Pack size
1 x 1's (in a single-dose glass vial) + diluent
Manufacturer
Not listed
Applicant (holder)
Sanofi-Aventis Nigeria Limited
Approved
3 Aug 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
2 Aug 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Jevtana Concentrate For Solution for Infusion is on the NAFDAC register with an active registration (A4-100070). 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. This is not medical advice. Always follow your doctor or pharmacist.

What Jevtana Concentrate For Solution for Infusion is used for

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

Boxed warning: NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. …
What it is used for

JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 )

Possible side effects

The following serious adverse reactions are discussed in greater detail in another section of the label: Bone Marrow Suppression [see Warnings and Precautions (5.1) ] Increased Toxicities in Elderly Patients [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.4) ] Renal Failure [see Warnings and Precautions (5.5) ] Urinary Disorders Including Cystitis [see Warnings and Precautions (5.6) ] Respiratory Disorders [see Warnings and Precautions (5.7) ] Use in Patients with Hepatic Impairment [see Warnings and Precautions (5.8) ] Most common all grades adverse reactions and labora …

Do not use if

JEVTANA is contraindicated in patients with: neutrophil counts of ≤1,500/mm 3 [see Warnings and Precautions (5.1) ] history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see Warnings and Precautions (5.3) ] severe hepatic impairment (total bilirubin >3 × ULN) [see Warnings and Precautions (5.8) ] Neutrophil counts of ≤1,500/mm 3 ( 2.2 , 4 ) History of severe hypersensitivity to JEVTANA or polysorbate 80 ( 4 ) Severe hepatic impairment (Tota …

Warnings

Bone marrow suppression (particularly neutropenia) and its clinical consequences (febrile neutropenia, neutropenic infections, and death): Monitor blood counts frequently to determine if dosage modification or initiation of G-CSF is needed. Closely monitor patients with hemoglobin 1 to ≤1.5 × ULN or AST >1.5 × ULN) and moderate (total bilirubin >1.5 to ≤3.0 × ULN and any AST) hepatic impairment, based on tolerability data in these patients [see Dosage and Administration (2.3) and Use in Specific Populations (8.7) ] . Administration of JEVTANA to patients with mild and moderate hepatic impairment should be undertaken with caution and close monitoring of safety. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary The safety and efficacy of JEVTANA have not been established in females. There are no human data on the use of JEVTANA in pregnant women to inform the drug-associated risk. In animal reproduction studies, intravenous administration of cabazitaxel in pregnant rats during organogenesis caused embryonic and fetal death at doses lower than the maximum recommended human dose [see Data ] . …

Storage

16.2 Storage JEVTANA injection and Diluent for JEVTANA: Store at 25°C (77°F); excursions permitted between 15°C–30°C (59°F–86°F). Do not refrigerate. 16.3 Handling and Disposal JEVTANA is a hazardous anticancer drug. …

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

Check your pack of Jevtana Concentrate For Solution for Infusion

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Jevtana Concentrate For Solution for Infusion

What is in Jevtana Concentrate For Solution for Infusion?

Jevtana Concentrate For Solution for Infusion contains Cabazitaxel (60 mg/1.5 mL), as concentrate for solution for infusion, according to its NAFDAC registration record.

Is Jevtana Concentrate For Solution for Infusion registered with NAFDAC?

Yes. Jevtana Concentrate For Solution for Infusion is listed on the NAFDAC register under registration number A4-100070, and its registration is active as of 27 October 2026.

Has Jevtana Concentrate For Solution for Infusion been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Jevtana Concentrate For Solution for Infusion in our automatically synced alert list.

How can I check that my pack of Jevtana Concentrate For Solution for Infusion is genuine?

Run a free authenticity scan with the NAFDAC number A4-100070, 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 Jevtana Concentrate For Solution for Infusion used for?

JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-contai (Summarised from the official U.S. FDA label for cabazitaxel. Always follow your doctor or pharmacist.)

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