Description
Rusfertide injection is used to treat erythrocytosis (high amount of red blood cells) in patients with polycythemia vera.
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 rusfertide 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 rusfertide 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
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.
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 rusfertide 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, red, irritated, tender, hard, or broken.
To use the vial:
- Wash your hands with soap and water before and after using this medicine.
- Do not use if any of the supplies are opened, damaged, or missing. Do not remove the diluent syringe from the carton by its plunger rod or syringe cap.
- Remove the cap from the vial. Clean the gray rubber stopper. Do not touch the rubber stopper of the vial.
- Open the vial adapter packaging. Do not let the vial adapter spike touch your hands or any surface. Do not remove the vial adapter from its plastic packaging.
- Place the vial on a flat surface. Using the other hand, place the vial adapter over the vial. Push the adapter straight down onto the top of the vial until it snaps on and it is fully attached. Do not attach the vial adapter at an angle. Do not remove the vial adapter from the vial after it is attached.
- Squeeze the plastic packaging lightly to lift and remove it from the vial adapter.
- Remove the syringe cap by turning it to the left. Attach the diluent syringe to the vial adapter by turning it to the right. Do not push the plunger.
- Place the vial on a flat surface. Inject all the diluent into the vial. Do not remove the syringe from the vial.
- Mix the diluent and medicine by slowly and gently swirling the vial in a circular motion for 2 minutes until the powder is fully dissolved. Do not shake the vial. The mixture may look foamy. Put the vial down and leave it for 1 minute to let the medicine settle. The diluent syringe plunger rod may rise up by itself, which is normal.
- Check the liquid in the vial. It should be clear with very little foam, colorless, and no particles in it. Do not use it if it is discolored or has particles in it.
- Make sure the syringe plunger rod is pressed all the way down to remove any air. Turn the vial upside down. Slowly pull the plunger to fill the syringe with the mixture.
- Hold the syringe by the body with one hand. With the other hand, remove the vial adapter by turning it to the left. Do not touch the syringe tip. Do not touch or push the plunger rod until you are ready to inject.
- Do not touch the open end of the needle. Attach the needle to the syringe by turning it to the right. Hold the syringe with the needle pointing up. Pull the needle shield back. Do not remove the needle shield from the needle. Firmly pull the cap straight off. Do not use the needle if it is damaged, bent, or has been dropped. Tap the syringe to move any air or bubbles to the syringe tip. Slowly push the plunger rod to remove air or bubbles.
- Pinch the skin. Insert the needle at a 45 to 90 degree angle. Slowly push the plunger rod to inject all the medicine. Pull the needle out from the skin. Do not recap the needle.
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 (powder for solution):
- For erythrocytosis:
- Adults—At first, 19 milligrams (mg) once a week. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 108 mg per week.
- Children—Use and dose must be determined by your doctor.
- For erythrocytosis:
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 inject once a week: If you miss a dose within 1 to 4 days, use it as soon as possible and go back to your regular dosing schedule. If you miss a dose for more than 4 days, use it as soon as possible then take your next injection 3 days later and go back to your regular dosing schedule.
If you inject two times a week: If you miss a dose within 1 to 2 days, use it as soon as possible then take your next injection 3 days later and go back to your regular dosing schedule. If you miss a dose for more than 2 days, skip the missed dose and go back to your regular dosing schedule.
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 the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Use the mixture within 4 hours after mixing. Throw away unused mixture after 4 hours.
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 to make sure this medicine is working properly. Blood tests may 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 using this medicine. Use an effective form of birth control during treatment and for at least 30 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause new or worsening thrombocytosis (increased platelets). Check with your doctor right away if you have bleeding, chest pain, leg pain or swelling, sudden loss of coordination, sudden severe headache, trouble breathing, or unusual bleeding or bruising.
Check with your doctor right away if you have 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. These may be symptoms of injection site reactions.
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
- chest pain
- leg pain or swelling
- pains in the chest, groin, or legs, especially the calves
- pale skin
- sudden loss of coordination
- sudden severe headache
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
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-80012051
