Description
Concizumab-mtci 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 concizumab-mtci 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 concizumab-mtci 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Antihemophilic Factor VIII Human
- Coagulation Factor VIIa
- Factor IX
- Prothrombin Complex
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—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 thigh 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 comes with a Medication Guide 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 tender, red, bruised, or hard, or into areas with moles, scars, or stretch marks.
Check the liquid in the pen. It should be clear and colorless to slightly yellow. It may have particles that you can see-through or are white. Do not use it if it is discolored, frozen, bent, or damaged.
You may use the prefilled pen from the refrigerator or allow it to warm to room temperature before using it or warm the pen in the palm of your hands. Do not warm it by using a heat source.
To use 60 mg/1.5 mL prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Push the needle straight onto the pen. Turn the needle clockwise until it is on tight. Pull off the outer and inner needle cap.
- Prime the pen. Select 0.4 mg when turning the dose selector. Hold the pen with needle pointing up. Press the dose button until it stops. You should see the medicine at the needle tip. If you do not see the medicine, repeat the priming steps up to 6 times. If there is still no medicine, do not use the pen.
- Turn the dose selector to select your prescribed dose. Insert the needle straight into your skin at a 90 degree angle. Press and hold the dose button down until you see a "0" in the dose counter. Slowly count to 6 while the needle is still in your skin. Remove the needle from your skin. You will hear or feel a click when the dose counter returns to "0".
- Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Recap the pen and store it without a needle attached.
To use 150 mg/1.5 mL and 300 mg/3 mL prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Push the needle straight onto the pen. Turn the needle clockwise until it is on tight. Pull off the outer and inner needle cap.
- Prime the pen. Select 1 mg when turning the dose selector. Hold the pen with needle pointing up. Press the dose button until it stops. You should see the medicine at the needle tip. If you do not see the medicine, repeat the priming steps up to 6 times. If there is still no medicine, do not use the pen.
- Turn the dose selector to select your prescribed dose. Insert the needle straight into your skin at a 90 degree angle. Press and hold the dose button down until you see a "0" in the dose counter. Slowly count to 6 while the needle is still in your skin. Remove the needle from your skin. You will hear or feel a click when the dose counter returns to "0".
- Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Recap the pen and store it without a needle attached.
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):
- For prevention of bleeding episodes:
- Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day on Day 1, followed by 0.2 mg/kg of body weight once a day on Day 2. After 4 weeks, your doctor may adjust your maintenance dose to 0.15 mg/kg to 0.25 mg/kg of body weight once a 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.
Starting dose (first 4 weeks of treatment): If you miss a dose, call your doctor or pharmacist for instructions.
Maintenance dose:
- For 1 missed dose: Use it as soon as possible.
- For 2 to 6 missed doses: Inject 2 doses as soon as possible and go back to your regular dosing schedule.
- For 7 or more missed doses: 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. You may store the opened prefilled pen at room temperature for up to 28 days. Throw away opened pen after 28 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 progress is closely monitored 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 7 weeks 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, pain in the chest, groin, or legs, especially the calves, slurred speech, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, trouble breathing, or vision changes 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
- Hives, itching, skin rash
- redness of the skin
Less common
- Difficulty swallowing
- fast heartbeat
- pains in chest, groin, or legs, especially calves of legs
- severe headaches of sudden onset
- sudden, severe weakness or numbness in the arm or leg
- sudden onset of slurred speech
- sudden trouble breathing for no apparent reason
- sudden vision changes
- swelling of the face, throat, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
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
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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