Description
Sibeprenlimab-szsi injection is used to reduce levels of protein in the urine (proteinuria) in patients with a type of kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease worsening quickly.
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 sibeprenlimab-szsi 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 sibeprenlimab-szsi 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.
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, active or
- Weakened immune system—Use with caution. This medicine may decrease your body’s ability to fight infection.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under your skin, usually in the stomach, thighs, or back of the upper arm. 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.
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, red, bruised, hard, or areas with moles or scars.
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.
Allow 15 to 30 minutes for the prefilled syringe to warm up to room temperature. Do not warm it any other way.
Check the liquid in the prefilled syringe. It should be clear to slightly pearly and colorless to yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake or roll. Do not use the syringe if it is damaged, dropped, broken, or the needle guard has been activated. Do not remove the grey needle cap until you are ready to inject.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Hold the middle of the prefilled syringe and lift it out of the box. Do not lift it by the plunger.
- It is normal to see air bubbles in the viewing window. Do not remove the air bubbles.
- Pull the needle cap straight off. Do not touch or recap the needle. Do not touch or pull back the plunger.
- Gently pinch the skin. Use a quick, dart-like motion to insert the needle into the pinched skin at a 45 degree angle.
- Push the plunger all the way down. Take your thumb off the plunger to allow the needle guard to cover 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 (prefilled syringe):
- For proteinuria:
- Adults—400 milligrams (mg) injected under the skin once every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- For proteinuria:
Missed Dose
Call your doctor or pharmacist for instructions.
If you miss a dose of this medicine, use it as soon as possible then use the next dose in 4 weeks.
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 prefilled syringe away from heat or direct sunlight. Keep the medicine in the original package until you are ready to use it. You may also store the medicine at room temperature. Do not put it back in the refrigerator once you have stored it at room temperature. Throw away unused medicine kept at room temperature after 7 days.
Throw away used syringes in a hard, closed container where 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.
This medicine may increase your chance of having serious infections. Check with your doctor right away if you have a cough or hoarseness, fever or chills, flu-like symptoms, lower back or side pain, or painful or difficult urination.
While you are being treated with sibeprenlimab-szsi, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given 30 days before or during treatment with this medicine.
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. Tell your doctor if you are using a medicine that can weaken the immune system.
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
- cough or hoarseness
- ear congestion
- fever or chills
- headache
- loss of voice
- lower back or side pain
- painful or difficult urination
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or 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
- 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
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-80008585
