What is Hemlibra used for?

1 INDICATIONS AND USAGE 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

What pharmaceutical form is Hemlibra available in?

Hemlibra: Roztwór do wstrzykiwań 30 mg/ml (podskórna)

Is Hemlibra OTC or prescription only?

Hemlibra requires a doctor's prescription.

What are the side effects of Hemlibra?

6 ADVERSE REACTIONS 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

Who should NOT take Hemlibra?

4 CONTRAINDICATIONS None. None ( 4 )

Does Hemlibra interact with other medications?

7 DRUG INTERACTIONS 7.1 Hypercoagulability with Concomitant Use of aPCC Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC [see Warnings and Precautions (5.1 , 5.2) ] . 7.2 Drug-Laboratory Test Interactions HEMLIBRA restores the tenase cofactor activity of missing activated factor VIII (FVIIIa). Coagulation laboratory tests based on intrinsic clotting (i.e., aPTT) measure the total clotting time including time needed for activation of FVIII to FV

Can Hemlibra be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 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. HEMLIBRA should be used during pregnancy only if the potential benefit for the mother o

How should Hemlibra be stored?

Storage and Handling 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. Prior to administration, if needed, unopened vials of HEMLIBRA may be stored out of and then returned to refrigeration. The temperature and total combined time out of refrigeration should not exceed 30°C (86°F) and 7 d

Who manufactures Hemlibra?

Roche Registration GmbH (Niemcy)

What ATC class does Hemlibra belong to?

Hemlibra: ATC B02BX06. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Hemlibra

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Hemlibra — Description, Dosage, Side Effects | PillsCard

11 DESCRIPTION Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X.‍‍‍‍‍‍‍ Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. HEMLIBRA (emicizumab-kxwh) injection is a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous injection supplied in single-dose vials containing emicizumab-kxwh at 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL, or 300 mg/2 mL. Each single-dose 12 mg vial contains a 0.4 mL solution of emicizumab-kxwh (12 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 30 mg vial contains a 1 mL solution of emicizumab-kxwh (30 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 60 mg vial contains a 0.4 mL solution of emicizumab-kxwh (60 mg), L-arginine (10.5 mg), L-histidine (1.2 mg), and poloxamer 188 (0.2 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 105 mg vial contains a 0.7 mL solution of emicizumab-kxwh (105 mg), L-arginine (18.3 mg), L-histidine (2.2 mg), and poloxamer 188 (0.4 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 150 mg vial contains a 1 mL solution of emicizumab-kxwh (150 mg), L-arginine (26.1 mg), L-histidine (3.1 mg), and poloxamer 188 (0.5 mg), adjusted to pH 6.0 with L-aspartic acid. Each single-dose 300 mg vial contains a 2 mL solution of emicizumab-kxwh (300 mg), L-arginine (52.3 mg), L-histidine (6.2 mg), and poloxamer 188 (1 mg), adjusted to pH 6.0 with L-aspartic acid.

⚠️ Warnings

Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted. Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.‍‍‍‍‍‍‍ Hemlibra is a colourless to slightly yellow solution. The solution should be discarded if particulate matter is visible or product is discoloured. Do not shake. Hemlibra solution for injection vials are for single-use only. A syringe, a transfer needle with filter or a vial adaptor with filter, and an injection needle are needed to withdraw Hemlibra solution from the vial and inject it subcutaneously. Please see below recommended features: A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution, whereas a 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL. Refer to the Hemlibra “Instructions for Use” for handling instructions when combining vials in a syringe. Different Hemlibra vial concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection to administer the prescribed dose. 1 mL syringe Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL. 2 to 3 mL syringe Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL. Transfer needle with filter Criteria for transfer needle with filter: Stainless steel with Luer‑lock connection, gauge 18 G, length 35 mm (1½″), containing a 5 micrometre filter and preferably with semi‑blunted tip. Vial adaptor with filter Criteria for vial adaptor with filter: Polypropylene with Luer-lock connection, integrating a 5 micrometre filter, fitting 15 mm vial neck outer diameter. Injection needle Criteria: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8″) or maximally 13 mm (½″), preferably including needle safety feature. Please see section 4.2 and package leaflet (section 7 Instructions for Use), for additional information on administration. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Hemlibra

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