Rapamune Oral Solution

Sirolimus Oral Solution

Consumer Medicine Information

This leaflet answers some common questions about Rapamune. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Rapamune against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

Rapamune belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received an organ transplant. It is used to prevent your body from rejecting the transplanted kidney. Rapamune is not recommended for patients who have received liver or lung transplants.

Your doctor may have prescribed Rapamune for another reason. Ask your doctor if you have any questions about why Rapamune has been prescribed for you.

Rapamune is not recommended for use in children, as there is limited information available on its effects in children.

This medicine is available only with a doctor’s prescription.

Rapamune is not habit-forming. 

Do not take Rapamune if you have an allergy to sirolimus or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include wheezing, shortness of breath, difficulty breathing, or a tight feeling in your chest, swelling of the face, lips, tongue or other parts of the body, rash, itching, hives or flushed red skin, dizziness or light-headedness.

If you are not sure whether this applies to you, check with your doctor.

Do not take Rapamune if the packaging is torn or shows signs of tampering.

Do not take Rapamune after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking Rapamune, contact your doctor.

Tell your doctor if:

1.You have any allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes.

2.You are pregnant or intend to become pregnant.

Like most immunosuppressive medicines, Rapamune is not recommended for use during pregnancy.

If you are a woman, before starting Rapamune you must be using effective contraception methods and you must continue contraception for 12 weeks after treatment has stopped. If you are unsure, or think you may have become pregnant, talk to your doctor or pharmacist. Discuss contraceptive options with your doctor.

3.You are breast-feeding or plan to breast-feed.

Like most immunosuppressive medicines, Rapamune is not recommended while you are breast-feeding. It is not known whether Rapamune passes into breast milk. Ask your doctor or pharmacist for advice before breast-feeding your baby.

4.You have or have had any medical conditions, especially the following:

liver problems or a disease which may have affected your liver

high fat levels in the blood

a condition called rhabdomyolysis, which may cause a variety of symptoms including muscle weakness and tenderness and temporary paralysis.

If you have not told your doctor about any of the above, tell them before you start taking Rapamune.

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Rapamune may interfere with each other. These include:

ciclosporin used to prevent transplant rejection

antibiotics such as rifampicin, clarithromycin, erythromycin and rifabutin

antifungal medicines such as ketoconazole, clotrimazole, fluconazole, voriconazole and itraconazole

medicines for high blood pressure or heart problems such as diltiazem and verapamil

epilepsy medicines such as carbamazepine, phenobarbitone and phenytoin

medicines for stomach ulcer or reflux such as cimetidine and cisapride

medicines to prevent nausea and vomiting such as metoclopramide

danazol which is used to treat endometriosis

bromocriptine which is used to treat Parkinson’s disease

protease inhibitors such as ritonavir, boceprevir, telaprevir and indinavir, which are used to treat HIV/AIDS

ACE inhibitors such as perindopril and ramipril which are used to treat high blood pressure

St. John’s wort.

These medicines may be affected by Rapamune, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Rapamune.

Rapamune is for oral use only.

Always take the medicine exactly as your doctor tells you.

Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.

Follow your doctor’s instructions exactly and never change the dose yourself. Do not stop taking your medicine unless your doctor tells you to.

The usual starting dose is 6 mg after transplantation and then 2 mg once daily. You will also need to take medicines such as ciclosporin and corticosteroids.

After 2 to 4 months, your doctor will start reducing the dose of ciclosporin you take and increasing your dose of Rapamune. Eventually your ciclosporin will be completely stopped. Your doctor will determine how much Rapamune you need to take.

Follow all directions given to you by your doctor and pharmacist carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

Take Rapamune consistently, either with or without food. Do not take Rapamune with grapefruit juice.

Follow these instructions to prepare Rapamune for use:

1.Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting counter clockwise. The first time you use a bottle of Rapamune Oral Solution,insert the syringe adaptor into the bottle until it is flush with the top of the bottle. Do not attempt to remove the syringe adaptor from the bottle once inserted.

2.Use a new dosing syringe for each does of Rapamune Oral Solution. With the plunger fully depressed, insert one of the dosing syringes into the opening in the adaptor.

3.Withdraw the exact amount of Rapamune as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the level of the oral solution is even with the mark on the dosing syringe for the prescribed dose. The bottle should remain in an upright position when withdrawing the solution. If bubbles form in the dosing syringe during withdrawal, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.

4.You may have been instructed to take your Rapamune oral solution at a particular time of day. If it is necessary to carry your medication with you, place a cap securely on the dosing syringe – the cap should snap into place. Then place the capped dosing syringe in the carrying case provided. Once in the syringe the medication may be kept at room temperature or refrigerated and used within 24 hours.

5.Empty the contents of the dosing syringe into a glass or plastic cup containing at least 60 mL of water or orange juice. Stir quickly for one minute and drink at once.

6.When mixed with water or orange juice Rapamune produces a white to off-white mixture.

7.Refill the glass or plastic cup with at least 120 mL of water or orange juice, stir quickly, and drink at once.

Do NOT use any liquids other than water or orange juice for dilution. Only use a glass or plastic cup to dilute Rapamune, and drink the preparation immediately after dilution. Use the dosing syringe and syringe cap once only and then discard.

Note

When refrigerated the solution in the bottle may separate or appear hazy. If this occurs, bring your Rapamune oral solution to room temperature and shake gently. The presence of a haze does not affect the quality of Rapamune.

Take Rapamune once a day at about the same time each day.

Taking Rapamune at the same time each day will have the best effect. It will also help you remember when to take it.

If you are also taking ciclosporin, then you must take Rapamune 4 hours after your ciclosporin dose.

You will need to take Rapamune for the rest of your life, or until your doctor decides to change your immunosuppressive medication.

If it is almost time for your next dose (within 4 hours), skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed and always take Rapamune and ciclosporin approximately 4 hours apart.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

Immediately telephone your doctor or the Poisons Information Centre (tel. 13 11 26 in Australia or 0800 764 766 in New Zealand), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Rapamune. Do this even if there are no signs of discomfort or poisoning. Take the labelled medicine bottle with you, even if it is empty.

You may need urgent medical attention. If you take too much Rapamune, your heart may start beating abnormally.

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Rapamune.

Attend all doctor’s appointments to monitor your condition.

Your doctor needs to closely monitor the level of Rapamune found in your blood to make sure the dose you are taking is best for your condition.

Take any antibiotic medication for as long as your doctor prescribes them.

Taking antibiotics helps prevent getting an infection.

Do not give Rapamune to anyone else even if they have the same condition as you.

Do not use Rapamune to treat any other complaints unless your doctor tells you to.

Do not stop taking Rapamune, or change the dosage, without checking with your doctor.

Kidney transplant patients need to remain on immunosuppressive medication.

Limit your exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor.

Immunosuppressive drugs such as Rapamune may increase the risk of developing cancer of the lymph glands and skin.

If you develop new lumps, spots or moles anywhere on your body, or you notice changes in existing lumps, spots or moles, tell your doctor.

This may be a sign of cancer. Immunosuppressant medicines, including Rapamune, may increase the risk of developing certain cancers, including skin cancer and lymphoma (cancer of the lymphatic system).

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Rapamune. Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Check with your doctor as soon as possible if you have any problems while taking Rapamune, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

If you get any side effects, do not stop taking Rapamune without first talking to your doctor.

Rapamune helps most people with kidney transplants but it may have unwanted side effects. However, since Rapamune is often taken in combination with other medicines, Rapamune may not have necessarily caused the side effects.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following. These may be very serious side effects. You may need urgent medical attention or hospitalisation:

signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing;

signs of excessive fluid on the lungs such as coughing, difficulty breathing and wheezing

swelling of hands, feet, limbs or abdomen or puffiness or swelling around the eyes due to fluid retention

constant “flu-like” symptoms such as fever, chills, sore throat, aching joints, swollen glands, cough, or any other signs of infection such as infection of a cut or scratch. Immuno-suppressive drugs may also increase the risk of getting an infection

new lumps, spots or moles, or changes to existing lumps, spots or moles, anywhere on your body. It is important to have these checked by a doctor as soon as possible

signs of a blood disorder such as tiredness, headaches, being short of breath when exercising, dizziness, paleness, nose bleeds, unusual bleeding or bruising

signs that blood clots may have formed, such as sudden severe headache, sudden loss of coordination, blurred vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood

signs of a disorder which may cause headache , confusion , seizures  and visual loss  or disturbances.

Tell your doctor if you notice any of the following:

burning sensation on urination or increased urgency to urinate

increased thirst and hunger

a fluid filled swelling on the skin

abnormal wound healing

fast heart beat

pain

diarrhoea

mouth ulcers and cold sores

nose bleed

pneumonia

acne

rash

fever

headache

constipation

nausea

symptoms of ovarian cyst, such as discomfort around the pelvis or abdomen or pain or pressure upon urination or bowel movements

changes in menstrual bleeding patterns.

These are common side effects of Rapamune.

Tell your doctor you are taking Rapamune if you also want to be vaccinated.

Rapamune may affect your response to vaccination.

Unwanted side effects that you may not be aware of whilst taking Rapamune include an increase in blood pressure and changes in the levels of red or white blood cells or substances carried in your blood (e.g. fat, cholesterol, protein, potassium or liver enzymes). During treatment your doctor may do blood tests to measure these changes.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Keep Rapamune in its original container. Store protected from light, in a refrigerator (2 to 8°C). Once the bottle has been opened, keep the contents in the fridge and use within one month. Discard syringe after one use only.

Heat can destroy some medicines.

Keep Rapamune where children cannot reach it.

If your doctor tells you to stop taking Rapamune or the solution has passed its expiry date, ask your pharmacist what to do with the left over solution.

Rapamune oral solution is a pale yellow to yellow solution.

Rapamune oral solution is supplied in 60 mL amber glass bottles.

Each mL of Rapamune contains 1 mg of the active ingredient, sirolimus.

The other ingredients are: Polysorbate 80 and Phosal 50 PG.

Phosal 50 PG contains:

phosphatidylcholine

propylene glycol

mono- and di-diglycerides

ethanol

soya fatty acids

ascorbyl palmitate.

Rapamune does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Rapamune is supplied in Australia by:

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free Number 1800 675 229

 

AUST R 73921

 

^® Registered Trade Mark

 

This leaflet was prepared in July 2019.