Description
Sotatercept-csrk injection is used to treat pulmonary arterial hypertension (PAH), which is high blood pressure that occurs in the arteries of your lungs. This medicine can improve your ability to exercise and perform your usual activities with fewer symptoms. It can also reduce the risk of your physical condition and symptoms worsening.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for 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 sotatercept-csrk 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 sotatercept-csrk injection in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, bleeding problems).
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:
- Bleeding problems (eg, stomach or bowel bleeding, intracranial hemorrhage) or
- Blood problems (eg, high amount of red blood cells) or
- Thrombocytopenia (low amount of platelets)—Use with caution. May make these conditions worse.
Proper Use
This medicine is given as a shot under the skin in your upper arm, upper thigh or stomach. It may be given at home if patients do not need to be in the hospital or clinic. If you are using this medicine at home, your healthcare provider will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.
Each package of Winrevair™ contains a patient information sheet. Ask your provider if you have any questions. Read this sheet carefully before beginning your treatment and each time you refill for any new information, and make sure you understand:
- How to prepare the medicine.
- How to inject the medicine.
- How to dispose of syringes, needles, and injection devices.
Allow 15 minutes for the kit to warm up to room temperature.
Check the powder in the vial. It should be white to off-white. Do not use it if it is damaged, discolored, or has particles in it.
This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Check the mixed liquid in the vial. It should be clear to slightly pearly and colorless to slightly brownish-yellow. Do not use it if it has clumps or powder in it.
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. Do not inject into skin areas that are bruised, damaged, sore, tender, or has red patches.
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 (vial):
- For pulmonary arterial hypertension:
- Adults—Dose is based on body weight and must be determined by your doctor. At first, the dose is usually 0.3 milligrams (mg) per kilogram (kg) injected under the skin every 3 weeks. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For pulmonary arterial hypertension:
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.
If you miss a dose, and it has been less than 3 days, use it as soon as possible then go back to your regular dosing schedule for the next dose. If you miss a dose, and it has been more than 3 days, ask your doctor 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.
You may store the kit at room temperature for up to 24 hours.
Use the mixed medicine right away. Throw away unused medicine if it has been more than 4 hours after mixing.
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 at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed before each of your first 5 doses of this medicine to check for unwanted effects.
Using this medicine could harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this treatment. Use an effective form of birth control during treatment with this medicine and for 4 months after the last dose to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.
This medicine may cause erythrocytosis (high amount of red blood cells). Check with your doctor right away if you have dizziness, fainting, flushing or redness of the skin, headache, irregular heartbeat, loss of appetite, nosebleeds, trouble breathing, unusual bleeding, or unusual tiredness.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Check with your doctor right away if you have bloody, black, or tarry stools, confusion, headache, nausea, vomiting of blood or material that looks like coffee grounds, or weakness. These may be symptoms of serious bleeding problems (eg, stomach or bowel bleeding, intracranial hemorrhage).
Some men and women 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 immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- dizziness
- fainting
- flushing or redness of the skin
- headache
- irregular heartbeat
- loss of appetite
- nosebleeds
- pinpoint red spots on the skin
- raised, dark red, wart-like spots on skin, especially when used on the face
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness
Incidence not known
- Bloody stools
- confusion
- nausea and vomiting
- vomiting of blood or material that looks like coffee grounds
- weakness
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
- Diarrhea
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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