Prigauro

PRIGAURO is a progestin hormone that acts on your ovaries and the womb and makes pregnancy less likely to occur.

• Endometriosis (a condition resulting from the appearance of endometrial tissue outside the uterus and causing pelvic pain).
• As a contraceptive to prevent you from becoming pregnant.
• In the treatment of endometrial cancer (cancer of the lining of the womb).
• In the treatment of renal cancer (cancer of the kidney(s) in men and women).

PRIGAURO should not be administered to you:

• If you are hypersensitive (allergic) to medroxyprogesterone acetate or any of the other ingredients of PRIGAURO (listed in section 6).
• If you have unexplained vaginal bleeding.
• If you have unexplained blood in your urine.
• If you have unexplained abnormalities with your breast(s).
• If you have or have previously had inflammation of the veins (thrombophlebitis).
• If you have liver problems.
• If you are or think you may be pregnant.
• If you have known or suspected breast cancer.
• If you have depression which is not well controlled with treatment.
• If you have had depression with previous use of hormonal contraception.

Warnings and precautions

Tell your doctor or other health care provider before being given the injection:

• if you have risk factors for osteoporosis including bone disease, excessive alcohol and/or tobacco use, a low body mass index (BMI) or eating disorder (e.g., anorexia or bulimia), strong family history of osteoporosis or chronic use of medicines that can reduce bone mass density such as anti-epileptics (used for seizures) or steroids,
• if you have a history of blood clots (e.g., in your lungs or your veins); tell your health care provider immediately if you experience signs of a blood clot such as pain, swelling and redness along a vein when using PRIGAURO,
• if you have a history of problems with the blood vessels or nerves in your eyes; tell your health care provider immediately if you experience a sudden change in your vision (blurry vision or a partial or complete loss of vision) when using PRIGAURO,
• if you have a history of abnormal or unexpected vaginal bleeding as you may need additional examination or testing before using PRIGAURO,
• if you are on treatment for depression,
• if you have had depression with previous use of hormonal contraceptives,
• if you have a substance abuse problem,
• if you have an underlying psychiatric disorder such as post-traumatic stress disorder or bipolar disorder,
• if you have a family history of mental disorders,
• if you have a history of physical or sexual abuse,
• if you suffer from diabetes as PRIGAURO may cause higher than normal blood glucose (sugar) levels,
• if you have a condition that may be affected by weight gain or fluid retention as PRIGAURO may cause these conditions to worsen (e.g., epilepsy, migraine, asthma or problems with your heart or kidneys).

Before starting treatment with PRIGAURO, you should undergo a complete medical examination that may include your blood pressure, breasts, abdominal and pelvic organs and a pap smear. Hormonal contraceptives, including PRIGAURO, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. If you experience mood changes and depression, contact your doctor for advice. The use of PRIGAURO may cause a decrease in the amount of calcium and other minerals in your bones. This can increase risk of developing brittle bones (osteoporosis) which can lead to bone breakages in later life. Your health care provider will assess this risk before giving you PRIGAURO and if you continue using PRIGAURO for more than 2 years. it is recommended that you have adequate calcium and vitamin D intake while using PRIGAURO. It is important to be aware that your menstrual cycle may be disrupted during treatment with PRIGAURO and up to 28 months following your last injection. At the beginning of your treatment, PRIGAURO may cause irregular bleeding and spotting. This usually decreases until complete absence of any bleeding, as such, the onset of menopause may be missed. Discuss with your doctor if you experience any abnormal vaginal bleeding. The results of some laboratory tests may be affected if you are using PRIGAURO. It is important to tell the health care provider you are using PRIGAURO if any medical tests and/or samples are being taken. PRIGAURO does not protect against sexually transmitted infections (STIs) including HIV infection (AIDS). Using PRIGAURO as directed will not expose you to STIs as it is a sterile injection product. Practising safe sex (i.e. using condoms) can lower the risk of STI transmission, including HIV, through sexual contact.

You will not be expected to give yourself PRIGAURO. It will be given to you by a person who is qualified to do so. PRIGAURO is an intramuscular injection (injected into the muscle) and will be administered by your doctor, nurse or other health care provider. PRIGAURO should be shaken well immediately before use.

Endometriosis

The recommended dose is 50 mg weekly or 100 mg every 2 weeks for at least 6 months.

Contraception

The recommended dose is 150 mg every three months. Your first injection of PRIGAURO should be given during the first 5 days after the onset of your menstrual period, within 5 days after giving birth if not breastfeeding, or, if exclusively breastfeeding, at or after the sixth week after giving birth to reduce risk that you are pregnant. If the time period since your last injection is more than 13 weeks, your health care provider will need to confirm that you are not pregnant before you are given another injection.

Consult with your health care provider when switching from other methods of birth control (e.g. oral contraceptive pill) to ensure correct timing of the first PRIGAURO injection to provide continuous birth control coverage.

Endometrial and renal cancer

The recommended dose is 400 mg to 1 000 mg per week. If improvement is noted within a few weeks or months and the disease appears stabilised, the dosage may be adjusted by your doctor. Your doctor will tell you how long your treatment with PRIGAURO will last. Do not stop any treatment unless your doctor tells you to do so. If you have the impression that the effect of PRIGAURO is too strong or too weak, tell your doctor or pharmacist.

If you receive more PRIGAURO than you should: Since a health care provider will administer PRIGAURO, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of PRIGAURO: Since a health care provider will administer PRIGAURO, it is unlikely that the dose will be missed. Do not receive a double dose to make up for forgotten individual doses.

PRIGAURO can have side effects. Not all side effects reported for PRIGAURO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRIGAURO, please consult your healthcare provider for advice.

If any of the following happens, stop taking PRIGAURO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• sudden skin rash or itching (especially affecting the whole body), swelling of the face, lips, tongue or throat, wheezing or difficulty in breathing,
• rash or itching,
• fainting. These are all very serious side effects. If you have them, you may have had a serious reaction to PRIGAURO. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• chest pain,
• angina,
• changes in the way your heart beats, for example, if you notice it beating faster,
• difficulty breathing,
• signs of recurrent infections such as fever or sore throat,
• less urine than is normal for you,
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

When used for contraception:

Frequent side effects

• nervousness,
• decreased sex drive,
• inability to reach orgasm,
• depression,
• difficulty sleeping,
• headache,
• dizziness,
• hot flushes,
• abdominal pain,
• abdominal discomfort,
• bloating,
• nausea,
• rash,
• acne,
• hair loss,
• backache,
• leg cramps,
• irregular and/or increased/decreased menstrual bleeding or spotting,
• absence of menstrual period,
• vaginal discharge,
• breast pain,
• breast tenderness,
• painful menstruation,
• pelvic pain,
• inflammation of the vagina,
• fluid retention,
• feeling weak,
• extreme tiredness,
• increased or decreased weight.

Less frequent side effects

• swelling under the skin, especially around face, throat, limbs or genitals,
• extended lack of ovulation,
• seizures (fits),
• drowsiness/sleepiness
• blood clots (e.g. in the lungs or veins) or inflammation of the veins,
• diarrhoea,
• yellowing of the skin or whites of the eyes (jaundice),
• liver disorder,
• excessive hair growth,
• itching,
• hives,
• muscle cramps,
• joint pain,
• muscle spasms,
• milky discharge from the breasts not as a result of pregnancy or breastfeeding,
• changes to the lining of the cervix causing pain, bleeding or discharge,
• changes in male or female characteristics,
• fever,
• injection site reactions including pain, lumps or change in skin colour,
• decreased glucose tolerance,
• decreased bone mineral density.

Frequency not known:

• severe depression with a higher risk of suicidal thoughts/behaviour and suicide,
• loss of fat tissue,
• osteoporosis (decrease in bone strength) including osteoporotic fractures,
• injection site reactions including persistent indentation or dimpling, lump or nodule at site of injection,
• pain or tenderness at site of injection.

When used for cancer:

Frequent side effects

• increased weight,
• tremors,
• increased sweating,
• swelling of feet and ankles,
• fluid retention.

Less frequent side effects

• rounded appearance of the face (‘moon-face’),
• inflammation of the veins,
• irregular and/or increased/decreased menstrual bleeding or spotting,
• fever.

Frequency not known

• osteoporosis (decrease in bone strength) including osteoporotic fractures,
• abnormal liver function test,
• severe depression with a higher risk of suicidal thoughts/behaviour and suicide,
• loss of fat tissue,
• injection site reactions including pain or tenderness at site of injection, persistent indentation or dimpling, lump or nodule at site of injection.

If you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PRIGAURO.

• Your doctor, nurse or pharmacist is responsible for storing PRIGAURO.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Store at or below 25 °C.
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• Protect from moisture.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.