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Hemlibra 150 mg

NAFDAC Reg. No. A6-100134 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Hemlibra 150 mg
NAFDAC number
A6-100134
Active ingredient
Emicizumab
Strength
150 mg/1 mL
Form
Solution for injection
Pack size
1 mL x 1's (in clear glass vial)
Manufacturer
Not listed
Applicant (holder)
Roche Products Limited
Approved
5 Nov 2023
Status
Active View on NAFDAC ↗
Registration valid to
30 Oct 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Hemlibra 150 mg is on the NAFDAC register with an active registration (A6-100134). 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 Hemlibra 150 mg is used for

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

Boxed warning: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur. …
What it is used for

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. ( 1 )

Possible side effects

The following serious adverse reactions are described elsewhere in the labeling: Thrombotic Microangiopathy Associated with HEMLIBRA and aPCC [see Warnings and Precautions (5.1) ] Thromboembolism Associated with HEMLIBRA and aPCC [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 10%) are injection site reactions, headache, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Do not use if

None. None ( 4 )

Warnings

Immunogenicity: Anti-emicizumab antibodies (including neutralizing antibodies) have developed in HEMLIBRA-treated patients. In case of clinical signs of loss of efficacy, promptly assess the etiology and consider a change in treatment if neutralizing antibodies are suspected. ( 5.3 , 12.6 , 14.3 ) Laboratory Coagulation Test Interference: HEMLIBRA interferes with activated clotting time (ACT), activated partial thromboplastin time (aPTT), and coagulation laboratory tests based on aPTT, including one-stage aPTT-based single-factor assays, aPTT-based Activated Protein C Resistance (APC-R), and Bethesda assays (clotting-based) for factor VIII (FVIII) inhibitor titers. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary There are no available data on HEMLIBRA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with emicizumab-kxwh. It is not known whether HEMLIBRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. …

Storage

Store HEMLIBRA vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. …

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

Check your pack of Hemlibra 150 mg

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 Hemlibra 150 mg

What is in Hemlibra 150 mg?

Hemlibra 150 mg contains Emicizumab (150 mg/1 mL), as solution for injection, according to its NAFDAC registration record.

Is Hemlibra 150 mg registered with NAFDAC?

Yes. Hemlibra 150 mg is listed on the NAFDAC register under registration number A6-100134, and its registration is active as of 5 November 2026.

Has Hemlibra 150 mg been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Hemlibra 150 mg in our automatically synced alert list.

How can I check that my pack of Hemlibra 150 mg is genuine?

Run a free authenticity scan with the NAFDAC number A6-100134, 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 Hemlibra 150 mg used for?

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding (Summarised from the official U.S. FDA label for emicizumab. Always follow your doctor or pharmacist.)

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