Description
Risankizumab-rzaa injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. Plaque psoriasis is a skin disease with red patches and white scales that do not go away. It is also alone or together with other medicines to treat active psoriatic arthritis.
Risankuzumab-rzaa injection is also used to treat moderate to severe active Crohn's disease and moderate to severe active ulcerative colitis.
This medicine is available only with your doctor's prescription.
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 risankizumab-rzaa 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 risankizumab-rzaa 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.
- Abatacept
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anifrolumab-fnia
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
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:
- Infection, or history of—Use is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have any chronic infection or history of a recurring infection.
- Liver disease—Use with caution. May make this condition worse.
- Tuberculosis infection, inactive—Should be treated first before starting treatment with this medicine.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given through an IV catheter placed into one of your veins or as a shot under your skin, usually in the stomach, thighs, or upper arms.
You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine. Do not use more medicine or use it more often than your doctor tells you to.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Risankizumab-rzaa comes in 4 forms: a prefilled pen, a prefilled syringe, a prefilled cartridge with on-body injector, and a vial. Your doctor will tell you which dosage form you should use. The vial is given by a nurse or other trained health professional.
Allow the medicine to warm to room temperature for 30 to 90 minutes for the prefilled pen,15 to 30 minutes for the prefilled syringe, and 45 to 90 minutes for the prefilled cartridge with on-body injector, without removing the medicine from the carton, before you use it. Do not warm the medicine in any other way.
To use the prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector:
- 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 areas where the skin is tender, bruised, red, hard, thick, scaly, or in areas with scars, stretch marks, or is affected by psoriasis.
- Check the liquid in the prefilled pen, syringe, or cartridge. It should be clear and colorless to yellow or slightly yellow and may contain small particles. Do not use the medicine if it is cloudy, discolored, or has flakes or large particles in it. Do not shake.
- Use a new needle and pen, syringe, or cartridge each time you inject your medicine. You might not use all of the medicine in each prefilled pen, syringe, or cartridge. Use each medicine only one time. Do not save an open medicine.
- Do not use the pen, syringe, or cartridge if it has been dropped or damaged. Do not remove the needle cover until you are ready to use it.
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 injectable dosage form (prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector):
- For moderate to severe active Crohn's disease and moderate to severe active ulcerative colitis:
- Adults—At first, a nurse or other trained health professional will give you this medicine through an IV catheter that is placed into one of your veins at Weeks 0, 4, and 8. Then, one 180 or 360 milligrams (mg) prefilled cartridge with on-body injector injected under your skin at different body areas at Week 12 and every 8 weeks after.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe plaque psoriasis and active psoriatic arthritis:
- Adults—150 mg prefilled pen or syringe injected under your skin at different body areas at Weeks 0 and 4, and every 12 weeks after.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe active Crohn's disease and moderate to severe active ulcerative colitis:
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.
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.
Keep the medicine in its original carton until you are ready to use it. Protect from light. Do not use the medicine if it has been frozen, even if it has been thawed.
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 may be needed to check for unwanted effects.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
It is important to check with your doctor if you have any symptoms of an infection, including fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have a cough, difficulty swallowing, dizziness, fast heartbeat, rash, itching, trouble breathing, or unusual tiredness or weakness after you receive the medicine.
Do not have any live vaccines (immunizations) while you are being treated with risankizumab-rzaa injection. Be sure to ask your doctor if you have any questions about this.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (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
- Body aches or pain
- chest pain or tightness
- chills
- confusion
- cough
- difficulty in breathing
- difficulty in moving
- dizziness
- ear congestion
- fainting
- fast heartbeat
- fever
- headache
- increase in bone pain
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- lightheadedness
- loss of voice
- muscle pain or stiffness
- pain in the joints
- painful blisters on the trunk of the body
- rapid, shallow breathing
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- itching of the genitals or other skin areas
- lower back or side pain
- pale skin
- scaling of the skin
- unusual bleeding or bruising
Rare
- Burning, itching, and pain in hairy areas, pus at the root of the hair
- hives or welts, skin rash
Incidence not known
- Clay colored stools
- dark urine
- difficulty swallowing
- loss of appetite
- nausea and vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain or tenderness
- swelling of the feet or lower legs
- yellow eyes or skin
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:
Less common
- Bleeding, blistering, burning, coldness, discoloration of the 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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