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What is the most important information I should know about Alhemo?
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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. Do not stop using Alhemo without talking to your healthcare provider. If you miss doses, or stop using Alhemo, you may no longer be protected against bleeding.
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Your healthcare provider may prescribe bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds.
See “How should I use Alhemo?” for more information on how to use Alhemo.
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What is Alhemo?
Alhemo 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 using Alhemo while 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.
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Do not use Alhemo if you are allergic to concizumab-mtci or any of the ingredients in Alhemo. See the end of this Medication Guide for a complete list of ingredients in Alhemo.
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Before using Alhemo, tell your healthcare provider about all of your medical conditions, including if you:
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- have a planned surgery. Your healthcare provider may stop treatment with Alhemo before your surgery. Talk to your healthcare provider about when to stop using Alhemo and when to start it again if you have a planned surgery.
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- are pregnant or plan to become pregnant. It is not known if Alhemo may harm your unborn baby.
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Females who are able to become pregnant
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- Your healthcare provider may do a pregnancy test before you start treatment with Alhemo.
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- You should use an effective birth control (contraception) during treatment with Alhemo and for 7 weeks after ending treatment. Talk to your healthcare provider about birth control methods that you can use during this time.
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- are breastfeeding or plan to breastfeed. It is not known if Alhemo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Alhemo.
Tell your healthcare provider 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 healthcare provider and pharmacist when you get a new medicine.
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How should I use Alhemo?
Read the Instructions for Use that comes with Alhemo for information about how to prepare and inject a dose of Alhemo, and how to properly throw away (dispose of) used Alhemo pens and needles.
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- Use Alhemo exactly as prescribed by your healthcare provider.
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- Your healthcare provider will provide instructions for stopping (discontinuing) your current treatment when switching to Alhemo.
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- Inject Alhemo 1 time a day.
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Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time.
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- Alhemo is given as an injection under the skin (subcutaneous injection) by you or a caregiver.
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- Ask your healthcare provider if you need to use a different injection technique. For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle).
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- Change (rotate) your injection site with each injection. Do not use the same site for each injection.
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- You will inject a larger dose (a loading dose) of Alhemo on your first day of treatment. Then your healthcare provider will prescribe a dose to inject 1 time a day until your maintenance dose is established.
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- To determine the right maintenance dose for you, your healthcare provider will do a blood test to check the amount of Alhemo in your blood. Your healthcare provider may do additional blood tests during treatment with Alhemo.
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- Your healthcare provider will prescribe your dose based on your weight. If your weight changes, tell your healthcare provider.
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- Your healthcare provider will provide information on the treatment of breakthrough bleeding during your treatment with Alhemo.
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- 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.
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If you miss a dose of Alhemo during the first 4 weeks of treatment, contact your healthcare provider right away. Your healthcare provider will tell you how much Alhemo to inject.
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If you miss a dose of Alhemo after your daily maintenance dose is established:
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- For 1 missed dose, continue your normal daily dose.
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- For 2 to 6 missed doses, give 2 doses as soon as you remember. Then continue your normal daily dose the next day.
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- For 7 or more missed doses, contact your healthcare provider right away as you will need to receive a new loading dose before continuing your normal daily dose.
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- If you are unsure about how much to Alhemo to inject, contact your healthcare provider.
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What are the possible side effects of Alhemo?
Alhemo may cause serious side effects, including:
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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:
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- swelling, warmth, pain, or redness of the skin
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- feeling short of breath or severe chest pain
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- headache
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- confusion
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- trouble speaking or moving
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- numbness in your face
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- eye pain or swelling
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- problems with your vision
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- sudden pain in your stomach or lower back area
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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:
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- itching on large areas of skin
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- redness or swelling of lips, tongue, face, or hands
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- trouble swallowing
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- shortness of breath
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- wheezing
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- tightness of the chest
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- pale and cold skin
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- fast heartbeat
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- dizziness due to low blood pressure
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The most common side effects of Alhemo include:
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- bruising, redness, bleeding, or itching at the site of injection
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- hives
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These are not all the possible side effects of Alhemo.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
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How should I store Alhemo?
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Before first use:
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- Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
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After first use:
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- Store the Alhemo pen in the refrigerator between 36°F to 46°F (2° to 8°C) or at room temperature below 86°F (30°C) for up to 28 days.
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- Write the date of first use in the space provided on the carton.
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- Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.
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- Store Alhemo with the cap on and keep it in the original carton to protect from light.
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- Do not store Alhemo in direct sunlight and keep away from direct heat.
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- When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator).
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- Do not freeze Alhemo.
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- Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).
Keep Alhemo and all medicine out of the reach of children.
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General information about the safe and effective use of Alhemo.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Alhemo for a condition for which it was not prescribed. Do not give Alhemo to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Alhemo that is written for health professionals.
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What are the ingredients in Alhemo?
Active ingredient: concizumab-mtci
Inactive ingredients: arginine hydrochloride, histidine, phenol, polysorbate 80, sodium chloride, sucrose, and water for injection. Hydrochloric acid and sodium hydroxide may be added for pH adjustment.
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Patent Information: http://novonordisk-us.com/products/product-patents.html
Alhemo® is a registered trademark of Novo Nordisk Health Care AG.
For information about Alhemo contact: Novo Nordisk Inc., 800 Scudders Mill Road Plainsboro, NJ 08536.
Manufactured by: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536 U.S. License No. 1261
At: Novo Nordisk A/S, Novo Allé 1, 2880 Bagsværd, Denmark
© 2024 Novo Nordisk
For more information, go to Alhemo.com or call 1-844-668-6732.
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