Description
Fitusiran injection is used to prevent or decrease the frequency of bleeding episodes in patients with hemophilia A or B with or without factor VIII or IX inhibitors.
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 fitusiran 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 fitusiran 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
- Anti-Inhibitor Coagulant Complex
- Coagulation Factor VIIa
- Factor IX
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:
- Gallbladder disease, history of or
- Liver disease—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, stomach, or upper arm. 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, damaged, bruised, or into areas with scars or with visible veins. Do not inject through clothes.
This medicine is available in 2 forms: a prefilled pen and a vial.
Allow 30 minutes for the prefilled pen or vial to warm up to room temperature. Do not warm using heat sources (eg, direct sunlight).
Check the liquid in the prefilled pen or vial. It should be clear and colorless to pale yellow. Do not use it if it is discolored, cloudy, or has flakes or particles in it. Do not shake.
To use the prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Do not use the prefilled pen if it has been dropped, damaged, or if the blue cap is missing or not attached. Do not use it if the window is yellow (has been used).
- Remove the blue cap by pulling it straight off. Do not twist it off. Do not touch the orange needle cover. Do not put the cap back on.
- Hold the prefilled pen at a 90 degree angle. Press down and hold the pen firmly against the skin until you cannot see the orange needle cover. You will hear a "click" sound. The window will start to turn yellow. Keep pressing the pen against the skin. You will hear a second click. You should see the yellow color in the window. If the window has not turned yellow, this means you may not have received the full dose.
- Pull the pen straight up. The orange needle cover will cover the needle.
To use the vial:
- Wash your hands with soap and water before and after using this medicine.
- Remove the protective cap from the vial. Attach the needle to the syringe. Do not touch the needle. Do not recap.
- Push the needle through the center of the rubber vial stopper. Leave the needle in and turn the vial upside down. Hold the syringe and vial with one hand. Make sure the tip of the needle is in the solution. With your other hand, pull back on the plunger rod to withdraw the prescribed dose.
- If air bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the plunger rod up to push the bubbles out of the syringe. Remove the needle from the vial.
- Gently pinch a fold of your skin. Insert the needle into the skin at a 45 to 90 degree angle. Slowly push the plunger rod all the way to the bottom of the syringe.
If you are using other medicines to treat or prevent bleeding (eg, clotting factor concentrate, bypassing agent), you will need to stop using them within 7 days after your first dose of this medicine.
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 (solution):
- For prevention of bleeding episodes:
- Adults and children 12 years of age and older—At first, 50 milligrams (mg) injected under the skin once every 2 months. Your doctor may adjust your dose as needed.
- 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.
Resume your dosing schedule either 1 time every month or 1 time every 2 months from the last dose, as directed.
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 prefilled pen at room temperature for up to 3 months. Do not put it back in the refrigerator. Throw the prefilled pen away after 3 months.
You may store the vial at room temperature. Do not put it back in the refrigerator.
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 that this medicine is working properly. Blood tests will be needed before starting this medicine and at month 1, 3, 5, and 6 during treatment with this medicine to check for unwanted effects.
If you can get pregnant, your doctor will ask you to use non-hormonal birth control before starting and during treatment with this medicine.
This medicine may increase your risk of having blood clots. Check with your doctor right away if you have chest pain or tightness, change in vision, confusion, coughing up blood, difficulty speaking, eye pain, fast heartbeat, fainting, headache, numbness or weakness in the face, arms, or legs, tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area, or trouble breathing.
Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Chills
- cough or hoarseness
- cold or flu-like symptoms
- dark urine
- fever
- headache
- loss of appetite
- lower back or side pain
- muscle aches
- painful or difficult urination
- sore throat
- stomach pain or tenderness
- stuffy or runny nose
- unusual tiredness or weakness
- yellow eyes or skin
Less common
- Gaseous stomach pain
- indigestion
- severe nausea or vomiting
- stomach fullness
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
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
- difficulty in moving
- joint pain
- muscle pain or stiffness
Less common
- Acid or sour stomach
- belching
- heartburn
- stomach discomfort or upset
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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