ALHEMO
Generic Name/API: concizumab-mtci
Manufacturer: Novo Nordisk Inc.
Dosage Forms & Strength & Pack Size:
Injection:
• 60 mg/1.5 mL (40 mg/mL) in a single-patient-use prefilled pen (3)
• 150 mg/1.5 mL (100 mg/mL) in a single-patient-use prefilled pen (3)
• 300 mg/3 mL (100 mg/mL) in a single-patient-use prefilled pen (3)
Storage:
Storage and Handling
Before first use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.
After first use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days. Write
the date of first use in the space provided on the carton. Discard the unused portion of the pen 28 days after first opening.
Store Alhemo® with the cap on and in the original carton to protect from light. Alhemo® should not be stored in direct sunlight, and the
Alhemo® pen should be kept away from direct heat. Do not freeze or store it close to a cooling element in a refrigerator (the part that cools the refrigerator). Do not use Alhemo® if it has been frozen or stored at temperatures above 86°F (30°C).
What is Alhemo®?
Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.
- It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI)
- It is not known if Alhemo® is safe and effective for hemophilia A and B with and without inhibitors in children younger than 12 years of age
What is the most important information I should know about Alhemo®?
- It is important to follow the daily dosing schedule of Alhemo® to stay protected against bleeding. This is especially important during the first 4 weeks of treatment to make sure a correct maintenance dose is established. Use Alhemo® exactly as prescribed by your healthcare provider (HCP). Do not stop using Alhemo® without talking to your HCP. If you miss doses or stop using Alhemo®, you may no longer be protected against bleeding
- Your HCP may prescribe bypassing agents during treatment with Alhemo®. Carefully follow your HCP’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds
Do not use Alhemo® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo®.
- Have a planned surgery. Your HCP may stop treatment with Alhemo® before your surgery. Talk to your HCP about when to stop using Alhemo® and when to start it again if you have a planned surgery
- Are pregnant or plan to become pregnant. It is not known if Alhemo® may harm your unborn baby
Females who are able to become pregnant- Your HCP may do a pregnancy test before you start treatment with Alhemo®.
- You should use an effective birth control (contraception) method during treatment with Alhemo® and for 7 weeks after ending treatment. Talk to your HCP about birth control methods that you can use during this time
- Are breastfeeding or plan to breastfeed. It is not known if Alhemo® passes into your breast milk. Talk to your HCP about the best way to feed your baby during treatment with Alhemo®
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your HCP and pharmacist when you get a new medicine.
How should I use Alhemo®?
- Change (rotate) your injection site with each injection. Do not use the same site for each injection
- To determine the right maintenance dose for you, your HCP will do a blood test to check the amount of Alhemo® in your blood. Your HCP may do additional blood tests during treatment with Alhemo®
- Do not share your Alhemo® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them
- If you miss a dose of Alhemo® during the first 4 weeks of treatment, contact your HCP right away. Your HCP will tell you how much Alhemo® to inject
What are the possible side effects of Alhemo®?
Alhemo® may cause serious side effects, including:
- Blood clots (thromboembolic events). Alhemo® may cause blood clots to form in blood vessels, such as in your arms, legs, heart, lung, brain, eyes, kidneys, or stomach. You may be at risk for getting blood clots during treatment with Alhemo® if you use high or frequent doses of factor products or bypassing agents to treat breakthrough bleeds, or if you have certain conditions. Get medical help right away if you have any signs and symptoms of blood clots, including: swelling, warmth, pain, or redness of the skin; headache; trouble speaking or moving; eye pain or swelling; sudden pain in your stomach or lower back area; feeling short of breath or severe chest pain; confusion; numbness in your face; and problems with your vision
- Allergic reactions. Alhemo® can cause allergic reactions, including redness of the skin, rash, hives, itching, and stomach-area (abdominal) pain. Stop using Alhemo® and get emergency medical help right away if you develop any signs or symptoms of a severe allergic reaction, including: itching on large areas of skin; trouble swallowing; wheezing; pale and cold skin; dizziness due to low blood pressure; redness or swelling of lips, tongue, face, or hands; shortness of breath; tightness of the chest; and fast heartbeat
The most common side effects of Alhemo® include: bruising, redness, bleeding, or itching at the site of injection, and hives.
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