MEDICATION GUIDE

Sirolimus Oral Solution

(sir oh' li mus)

What is the most important information I should know about sirolimus oral solution?

Sirolimus oral solution can cause serious side effects, including:

1. Increased risk of getting infections. Serious infections can happen including infections caused by viruses, bacteria, and fungi (yeast). Your doctor may put you on medicine to help prevent some of these infections. Call your doctor right away if you have symptoms of infection including fever or chills while taking sirolimus oral solution.

2. Increased risk of getting certain cancers. People who take sirolimus oral solution have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer.

Sirolimus oral solution has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take sirolimus oral solution after a liver or lung transplant. You should not take sirolimus oral solution if you have had a liver or lung transplant without talking with your doctor.

See the section "What are the possible side effects of sirolimus oral solution?" for information about other side effects of sirolimus oral solution.

What is sirolimus oral solution?

Sirolimus oral solution is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body's immune system recognizes the new organ as a "foreign" threat and attacks it.

Sirolimus oral solution is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide:

• if sirolimus oral solution is right for you, and
• how to best use it with cyclosporine and corticosteroids after your transplant.

It is not known if sirolimus oral solution is safe and effective in children under 13 years of age.

Sirolimus is a prescription medicine also used to treat lymphangioleiomyomatosis (LAM). LAM is a rare progressive lung disease that affects predominantly women of childbearing age.

Who should not take sirolimus oral solution?

Do not take sirolimus oral solution if you are allergic to sirolimus or any of the other ingredients in sirolimus oral solution. See the end of this leaflet for a complete list of ingredients in sirolimus oral solution.

What should I tell my doctor before taking sirolimus oral solution?

• have liver problems
• have skin cancer or it runs in your family
• have high cholesterol or triglycerides (fat in your blood)
• are pregnant or are a female who can become pregnant. Sirolimus oral solution can harm your unborn baby. You should not become pregnant during treatment with sirolimus oral solution and for 12 weeks after ending treatment with sirolimus oral solution. In order to avoid pregnancy, a female who can get pregnant should use effective birth control during treatment and for 12 weeks after your final dose of sirolimus oral solution. Talk with your doctor about what birth control method is right for you during this time. Tell your doctor right away if you become pregnant or think you are pregnant during treatment with sirolimus oral solution or within 12 weeks after your final dose of sirolimus oral solution.
• It is not known whether sirolimus passes into breast milk; however, there is a risk of serious side effects in breastfed infants. You and your doctor should decide about the best way to feed your baby if you take sirolimus oral solution.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using sirolimus oral solution with certain medicines may affect each other causing serious side effects.

Sirolimus oral solution may affect the way other medicines work, and other medicines may affect how sirolimus oral solution works.

Especially tell your doctor if you take:

• a medicine to lower your cholesterol or triglycerides
• cyclosporine (including Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf) or other medicines that suppress the immune system
• an antibiotic
• an antifungal medicine
• a medicine for high blood pressure or heart problems
• an anti-seizure medicine
• medicines used to treat stomach acid, ulcers, or other gastrointestinal problems
• bromocriptine mesylate (Parlodel, Cycloset)
• danazol
• letermovir (Prevymis)
• medicines to treat HIV or hepatitis C
• St. John's Wort
• cannabidiol (Epidiolex)

How should I take sirolimus oral solution?

• Read the Instructions for Use that comes with your sirolimus oral solution for information about the right way to take sirolimus oral solution.
• Take sirolimus oral solution exactly as your doctor tells you to take it.
• Your doctor will tell you how much sirolimus oral solution to take and when to take it. Do not change your dose of sirolimus oral solution unless your doctor tells you to.
• If you also take cyclosporine (Gengraf, Neoral, Sandimmune), you should take your sirolimus oral solution and cyclosporine about 4 hours apart.
• Do not stop taking sirolimus oral solution or your other anti-rejection medicines unless your doctor tells you to.
• Your doctor will check the levels of sirolimus in your blood. Your doctor may change your dose of sirolimus oral solution depending on your blood test results.
• Sirolimus oral solution is taken by mouth 1 time each day.
• Take each dose of sirolimus oral solution the same way, either with or without food. Food can affect the amount of medicine that gets into your bloodstream. Taking each dose of sirolimus oral solution the same way helps keep your blood levels of sirolimus more stable. Do not take sirolimus oral solution with grapefruit juice.
• Sirolimus oral solution can develop a slight haze when it is refrigerated. If this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away.
• If you get sirolimus oral solution on your skin, wash the area with soap and water.
• If you get sirolimus oral solution in your eyes, rinse your eyes with water.
• If you have taken more medicine than you were told, contact a doctor or go to the nearest hospital emergency department right away.

What should I avoid while taking sirolimus oral solution?

• Avoid receiving live vaccines while taking sirolimus oral solution. Some vaccines may not work as well while you are taking sirolimus oral solution.
• Limit your time in sunlight and UV light. Cover your skin with clothing and use a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer with sirolimus oral solution.

What are the possible side effects of sirolimus oral solution?

Sirolimus oral solution may cause serious side effects, including:

• See "What is the most important information I should know about sirolimus oral solution?"
• Serious allergic reactions. Tell your doctor or get medical help right away if you get any of following symptoms of an allergic reaction:
  • swelling of your face, eyes, or mouth
  • trouble breathing or wheezing
  • throat tightness
  • chest pain or tightness
  • feeling dizzy or faint
  • rash or peeling of your skin
• Swelling (edema). Fluid may collect in your hands and feet and in various tissues of your body, including in the sac around your heart or lungs. Call your doctor if you have trouble breathing.
• Poor wound healing. Sirolimus oral solution may cause your wounds to heal slowly or not heal well. Tell your doctor if you have any redness or drainage, your wound does not heal, or the wound opens up.
• Increased levels of cholesterol and triglycerides (lipids or fat) in your blood. Your doctor should do blood tests to check your lipids during treatment with sirolimus oral solution. Your doctor may prescribe treatment with diet, exercise, or medicine if your lipid levels are too high. During treatment with sirolimus oral solution, your blood levels of cholesterol and triglycerides may remain high even if you follow your prescribed treatment plan.
• Effects on kidney function. When sirolimus oral solution is taken with cyclosporine (Gengraf, Neoral, Sandimmune), the function of your transplanted kidney may be affected. Your doctor should regularly do tests to check your kidney function while you are taking sirolimus oral solution with cyclosporine (Gengraf, Neoral, Sandimmune).
• Increased protein in your urine. Your doctor may regularly test your urine protein.
• Increased risk for viral infections.
  • Certain viruses can live in your body and cause active infections when your immune system is weak. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
  • A certain virus can cause a rare serious brain infection called Progressive Multifocal Leukoencephalopathy (PML). PML usually causes death or severe disability. Call your doctor right away if you notice any new or worsening medical problems such as:
    • confusion
    • sudden change in thinking, walking, strength on one side of your body
    • other problems that have lasted over several days
• Lung or breathing problems. This can sometimes lead to death. Tell your doctor if you have a new or worsening cough, shortness of breath, difficulty breathing or any new breathing problems. Your doctor may need to stop sirolimus oral solution or lower your dose.
• Blood clotting problems. When sirolimus oral solution is taken with cyclosporine or tacrolimus, you may develop a blood clotting problem. Tell your doctor if you get any unexplained bleeding or bruising.
• Possible harm to your unborn baby. Sirolimus oral solution can harm your unborn baby. You should not become pregnant during treatment with sirolimus oral solution and for 12 weeks after ending treatment with sirolimus oral solution. See “What should I tell my doctor before taking sirolimus oral solution?”.

The most common side effects of sirolimus oral solution in people with renal transplant include:

• high blood pressure
• pain (including stomach and joint pain)
• diarrhea
• headache
• fever
• urinary tract infection
• low red blood cell count (anemia)
• nausea
• low platelet count (cells that help blood to clot)
• high blood sugar (diabetes)

The most common side effects of sirolimus oral solution in people with LAM include:

• mouth sores
• diarrhea
• stomach pain
• nausea
• sore throat
• acne
• chest pain
• upper respiratory tract infection
• headache
• dizziness
• sore muscles

Other side effects that may occur with sirolimus oral solution:

• Sirolimus oral solution may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
• Sirolimus oral solution may affect fertility in males and may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of sirolimus oral solution. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store sirolimus oral solution?

Sirolimus oral solution:

• Store bottles of sirolimus oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Protect from light.
• If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
• When a bottle of sirolimus oral solution is opened, it should be used within 1 month.
• Use any diluted sirolimus oral solution right away.

Do not use sirolimus oral solution after the expiration date. The expiration date refers to the last day of that month.

Safely throw away medicine that is out of date or no longer needed.

Keep sirolimus oral solution and all medicines out of the reach of children.

General Information about the safe and effective use of sirolimus oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sirolimus oral solution for a condition for which it was not prescribed. Do not give sirolimus oral solution to other people even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about sirolimus oral solution. If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about sirolimus oral solution that is written for health professionals.

What are the ingredients in sirolimus oral solution?

Active ingredients: sirolimus

Inactive ingredients: Phosal 50 PG® (ascorbyl palmitate, ethanol, lysophosphatidylcholine, phosphatidylcholine, propylene glycol, sunflower mono- diglycerides, and water) and polysorbate 80.

Sirolimus oral solution contains 1.5% to 2.5% ethanol.

All registered trademarks in this document are the property of their respective owners. 

This Medication Guide has been approved by the U.S. Food and Drug Administration.

APOTEX INC.

SIROLIMUS ORAL SOLUTION

1 mg/mL

Manufactured By	Manufactured For
Apotex Inc.	Apotex Corp.
Toronto, Ontario	Weston, Florida
Canada M9L 1T9	USA 33326

Revised: July 2023

Rev. 8