Alhemo 60 mg/1.5 mL (40 mg/mL) subcutaneous pen injector

Generic name:
Concizumab - injection

Pronunciation
(kon-SIZ-ue-mab)

Brand name(s)
Alhemo

This medication is used by people with a certain inherited bleeding problem (hemophilia A or B) to help prevent or lessen how often you have bleeding problems. Concizumab belongs to a class of medications known as monoclonal antibodies. It works by helping your blood to clot normally, which helps prevent bleeding due to hemophilia.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually daily. The injection is given in the thighs or abdomen (except for a 2-inch area around your belly button). The dosage is based on your medical condition, weight, and response to treatment.

Stop the prophylactic use of bypassing agents 1 to 2 days before starting concizumab. Ask your healthcare professional for more information about the use of these other products and what to do if you have breakthrough bleeding.

This product may contain clear or white particles. Before using, check this product for cloudiness, large particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, stretch marks, or skin that is tender, bruised, red, or hard. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Redness, itching, swelling, bruising, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause serious problems from blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are also using other products (such as Factor VIII or IX for breakthrough bleeding), have a history of heart/blood vessel disease, cancer, or if you are immobile (such as on very long plane flights or being bedridden). Get medical help right away if you develop symptoms of serious blood clots, such as shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using concizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop using concizumab before your surgery. Ask for specific instructions about stopping or starting this medication.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using concizumab. Concizumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 7 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as blood clotting tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood clotting tests, weight, concizumab blood levels) must be done while you are using this medication. Keep all medical and lab appointments.

It is very important to follow your treatment regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of concizumab.

Store in the refrigerator. Do not freeze. Keep the medication in the original package to protect it from light. Once opened, this medication may also be stored at room temperature if needed and expires after 28 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.