Description
Marstacimab-hncq injection is used to prevent or decrease the frequency of bleeding episodes in patients with hemophilia A (congenital Factor VIII deficiency) or hemophilia B (congenital Factor IX deficiency).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of marstacimab-hncq injection in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of marstacimab-hncq injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood clots or
- Infection or
- Injury—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the buttocks, upper arms, thighs, or stomach. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine. This medicine must not be injected into a vein .
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are bony, tender, red, bruised, hard, or sore, or into areas with scars or stretch marks.
This medicine is available in 2 forms: a prefilled pen or a prefilled syringe.
Allow the medicine to warm to room temperature for 15 to 30 minutes. Do not warm using other heat sources (eg, hot water or microwave).
Check the liquid in the pen or syringe. It should be clear and colorless to light yellow. Do not use it if it is frozen, thawed, cloudy, dark yellow, or has flakes or particles in it. Do not shake. Do not use it if it is damaged or has been dropped.
To use the prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Twist and pull off the cap. Do not put or press your hand over the needle guard.
- Hold the pen at a 90 degree angle against your skin. Firmly push the pen down straight against your skin and keep pushing until the injection is complete. You will hear the first "click" when the injection starts.
- Keep pushing the pen firmly until you see the yellow bar move across the window. You will hear a second "click" when injection is almost complete. Slowly count to 5 after you hear the second "click" and until the yellow bar completely fills the window to make sure you receive the full dose.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Remove the needle cover. Do not touch the needle.
- Gently pinch the skin. Insert the needle at about a 45 degree angle. Do not hold or push the plunger while inserting the needle.
- Push the plunger rod all the way down, until the barrel is empty. Slowly count to 5 after the plunger rod has been fully pushed down before removing the needle from your skin.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled pen or prefilled syringe):
- For prevention of bleeding episodes:
- Adults and children 12 years of age and older—At first, 300 milligrams (mg) or two 150 mg injected under the skin. After 1 week, a maintenance dose of 150 mg every week is injected under the skin on the same day each week, any time of the day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For prevention of bleeding episodes:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Maintenance dose of 150 milligrams (mg): If you miss a dose and it is more than 13 days, call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. If needed, you may store the prefilled pen or prefilled syringe at room temperature for up to 7 days. Do not return it to the refrigerator. Throw the medicine away if it has been left out of the refrigerator for more than 7 days.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress closely at regular visits while you or your child are receiving this medicine to make sure it is working properly. Blood tests will be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for 2 months after the last dose to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may increase your risk of having blood clots. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing, or numbness or weakness while you are receiving this medicine.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty in swallowing, fast heartbeat, skin itching, rash or redness, swelling of the face, throat, or tongue, or trouble breathing.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or medical tests.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- headache
Less common
- Itching skin
Incidence not known
- Difficulty breathing or swallowing
- fast heartbeat
- pain the chest, groin, or legs, especially in the calves
- slurred speech
- sudden, severe weakness or numbness in the arm or leg
- sudden loss of coordination
- swelling of the face, throat, or tongue
- vision changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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