Description
Garetosmab-grts injection is used to reduce the formation of new heterotopic ossification (bone forms in the soft tissues) and flare-ups in patients with fibrodysplasia ossificans progressiva (FOP).
This medicine is to be given only by or under the direct supervision of your doctor.
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 garetosmab-grts injection in the pediatric population. 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 garetosmab-grts 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.
Proper Use
A doctor or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 60 minutes. This medicine is given once every 4 weeks.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause skin and soft tissue infections (eg, abscesses and cellulitis). Check with your doctor right away if you have a fever, accumulation of pus, or itching, pain, redness, swelling, tenderness, warmth, or a lump under the skin at the injection site.
This medicine may cause bleeding problems, including epistaxis (nosebleeds). Check with your doctor right away if you have a nosebleed that is severe or heavy, does not stop with first-aid measures (eg, pinching your nose with pressure), or lasts more than 20 minutes.
Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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 or nurse immediately if any of the following side effects occur:
More common
- Accumulation of pus
- bloody nose
- fever
- itching, pain, redness, swelling, tenderness, warmth, or a lump under the skin at the injection site
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
- Blemishes on the skin
- burning, itching, and pain in hairy areas, pus at the root of the hair
- hair loss of eyebrows or eyelashes
- increased hair growth
- irritation, soreness, swelling, or inflammation of the mouth
- loosening of the fingernails
- pimples
- redness or soreness around the fingernails
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.
DRG-80012059
