A medical practitioner qualified to care for patients with haemophilia will start you on treatment with Hemlibra. Always use Hemlibra exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Each time you use Hemlibra, record the name and batch number of the medicine.
How much Hemlibra to use
First dose
Weeks 1 to 4: The dose is 3 milligrams for every 1 kilogram you weigh, injected under the skin (subcutaneously) once a week.
Maintenance doses
From week 5 and onwards: The dose of Hemlibra is dependent on your weight and your doctor should tell you how much to inject. The dose is either:
- 1,5 mg/kg once weekly, or
- 3 mg/kg every two weeks, or
- 6 mg/kg every four weeks
How Hemlibra is given
If you or your caregiver gives an injection of Hemlibra, you must carefully read and follow the instructions under “Instructions for use” below.
- Hemlibra is given by injection under the skin (subcutaneously)
- Your doctor or nurse will show you and/or your caregiver how to inject Hemlibra
- Once you and/or your caregiver have been trained, you should be able to inject this medicine at home, by yourself or with the help of a caregiver
- Do not inject Hemlibra into a vein or muscle. To correctly insert the needle under the skin, pinch a fold of loose skin at the clean injection site with your free hand. Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injecting into a muscle could result in an uncomfortable injection
- Prepare and give the injection under clean and germ-free conditions using “aseptic technique”. You will be given more information about this by your doctor or nurse
- Before using Hemlibra, check the solution for particles or discolouration. The solution should be colourless to slightly yellow. Do not use Hemlibra if you notice that it is cloudy, discoloured, or contains visible particles.
Where to inject Hemlibra
- Your doctor will show you and/or your caregiver which areas of the body should be injected with Hemlibra,
- The recommended places to give an injection are: the front of the waist (lower abdomen), upper outer arms, or the front of the thighs. Only give an injection in the recommended places,
- Each time you or your caregiver gives an injection, use a different area of the body to the one you used before, using one of the recommended places (front of the waist, upper outer arms, or the front of the thighs),
- Do not give injections where the skin is red, bruised, tender, hard, or areas where there are moles or scars,
- When using Hemlibra, other medicines injected under the skin should be given in a different area.
Using syringes and needles
- A syringe, a transfer needle with filter, a transfer needle, a vial adaptor or vial adaptor with filter and an injection needle are needed to withdraw the Hemlibra solution from the vial into the syringe and inject it under the skin,
- Syringes, transfer needles with filter, transfer needles, vial adaptors, vial adaptors with filter and injection needles are not provided in this pack. For more information, see “What Hemlibra looks like and contents of the pack”, what is needed for Hemlibra administration and is not contained in this pack,
- Make sure that you use a new injection needle for each injection and dispose of it after a single use,
- A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution.
- A 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL of Hemlibra solution.
- When used together with a vial adaptor, a low dead space plunger syringe must be used.
Your doctor will tell you how long your treatment with Hemlibra will last. Do not stop treatment without consulting with your doctor. If you have the impression that the effect of Hemlibra is too strong or too weak, tell your doctor or pharmacist.
Use in children and adolescents
Hemlibra can be used in children and adolescents of all ages (for the recommended dose, see “How to use Hemlibra”). If a child would like to self-inject the medicine, the child’s healthcare provider and the parent or caregiver should agree on whether it is appropriate for them to do so. Self-injection for children below the age of 7 years is not recommended.
If you take more Hemlibra than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you or your caregiver uses more Hemlibra than you are supposed to, tell your doctor immediately. This is because you may be at risk of developing side effects such as blood clots.
If you forget to take Hemlibra
If you forget your scheduled weekly injection, inject the forgotten dose as soon as possible approximately 24 hours before the day of the next scheduled dose. Then, continue to inject the medicine once a week as scheduled. Do not inject a double dose to make up for a forgotten dose.
If you stop taking Hemlibra
Do not stop using Hemlibra without talking to your doctor. If you stop using Hemlibra, you may no longer be protected against bleeding. If you have any further questions on the use of Hemlibra, ask your doctor, pharmacist or nurse.
