TM Owner Bayer
Jivi 2000IU Injection
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Indications & Clinical Uses
- Jivi 2000 IU is a freeze-dried powder containing damoctocog alfa pegol, a PEGylated recombinant human coagulation factor VIII, which is reconstituted with the supplied liquid and injected slowly into a vein.
- It is approved for previously treated adults and children aged 7 years and over with haemophilia A (congenital factor VIII deficiency) to treat and control bleeding episodes, to cover surgery, and as routine prophylaxis to reduce how often bleeds occur.
- Jivi is not approved for children under 7 years or for previously untreated patients, and it is not used for von Willebrand disease.
- Dosing is individualised in international units per kilogram: roughly 10 to 50 IU/kg for on-demand treatment depending on the bleed, and for prophylaxis typically 30 to 40 IU/kg twice weekly in people aged 12 and over, or 60 IU/kg twice weekly in children aged 7 to under 12.
- The marketing authorisation holder is Bayer.
Side Effects
- Jivi has NO boxed warning.
- The most frequently reported side effects, each in at least 5 percent of people, are headache, fever, cough and abdominal pain; nausea and injection-site reactions also occur.
- Two risks matter most.
- Allergic reactions, including anaphylaxis, can occur: stop the injection and get emergency help if you develop hives, widespread rash, tightness of the chest, wheezing, swelling of the face, lips or throat, dizziness or faintness.
- Second, the body can make neutralising antibodies (inhibitors) against factor VIII, which show up as bleeds that no longer stop with the usual dose; this needs urgent testing.
- Because Jivi is attached to polyethylene glycol, some people develop an immune response to PEG that causes an acute reaction or a sudden loss of effect, most often early in treatment and more often in young children.
- Always keep a treatment diary and report any change in response.
Precautions & Warnings
- Jivi is for intravenous injection only and must never be given into a muscle or under the skin.
- Use only the supplied diluent and transfer device, let the reconstituted solution reach room temperature, inspect it for particles, and inject within 3 hours; do not refrigerate after mixing.
- Recovery and factor VIII levels should be monitored, and testing for inhibitors is advised if bleeding is not controlled by the expected dose.
- Jivi is not recommended in children under 7 years because of a greater risk of hypersensitivity and of losing efficacy.
- Tell your healthcare provider about any previous reaction to a factor VIII product or to PEG-containing medicines.
- There is limited information on use in pregnancy and breastfeeding, so it is used only if clearly needed.
- Vials are stored in a refrigerator at 2 to 8 degrees Celsius, may be kept below 25 degrees for one period of up to 6 months, and must not be frozen.
Avoid Interactions
- No specific medicine interactions have been established for Jivi, and factor VIII products are not metabolised through the usual liver enzyme pathways, so classic interactions such as grapefruit or CYP3A inhibitors do not apply.
- The practical concerns are pharmacy-level: do not mix Jivi with any other medicine, diluent or infusion fluid, use only the reconstitution kit supplied in the pack, and give it through a separate line rather than adding it to a running drip.
- Medicines that increase bleeding risk, such as aspirin, other non-steroidal anti-inflammatory drugs and anticoagulants, should be discussed with your haemophilia centre before use, and intramuscular injections are generally avoided.
- Emicizumab and other non-factor therapies alter factor VIII laboratory assays, so tell the laboratory which products you are using.
- Tell every healthcare provider, including dentists and surgeons, that you have haemophilia A and are using Jivi, and list all prescription medicines, herbal products and supplements.
References
Frequently Asked Questions
Jivi (damoctocog alfa pegol) is a long-acting factor VIII replacement for previously treated adults and children aged 7 and over with haemophilia A. It treats and controls bleeds, covers surgery, and is used as regular prophylaxis to reduce how often bleeding happens.
Jivi (damoctocog alfa pegol) is mixed with the supplied diluent and injected slowly into a vein. Doses are set in international units per kilogram: about 10 to 50 IU/kg for a bleed, and 30 to 40 IU/kg twice weekly for prophylaxis in people aged 12 and over. Use within 3 hours of mixing.
The commonest Jivi side effects are headache, fever, cough and abdominal pain. Jivi has no boxed warning. Get emergency help for signs of an allergic reaction such as hives, wheezing, chest tightness or swelling of the face or throat, and tell your centre if bleeds stop responding to your usual dose.
Do not mix Jivi (damoctocog alfa pegol) with any other medicine or infusion fluid, and use only the reconstitution kit in the pack. Never inject it into a muscle. Check with your haemophilia centre before taking aspirin, other anti-inflammatory painkillers or blood thinners, which increase bleeding risk.
Store Jivi vials in a refrigerator at 2°C to 8°C and do not freeze. They may be kept below 25°C for one single period of up to 6 months, after which they must be used or discarded. Protect from light, and use the reconstituted solution within 3 hours at room temperature.
Jivi (damoctocog alfa pegol) is approved only for previously treated children aged 7 years and over. It is not recommended below 7 years because younger children had more hypersensitivity reactions and more loss of effect, partly linked to an immune response to the PEG part of the molecule.
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