DapiRing 25 mg

The DapiRing is used to reduce the chance of women 18 years and older getting a HIV-1 infection during vaginal sex . It should always be used in combination with safer sex practices and should be used when oral PrEP is not/cannot be used or is not available. The DapiRing contains dapivirine, a medicine that can reduce the risk to become HIV-1 infected. The medicine is released from the ring into the vagina slowly over 28 days.

The DapiRing must be kept in the vagina all the time until it is replaced with a new ring after 28 days. The DapiRing is an off-white coloured ring that is easy to bend and should only be used in the vagina. Ask your healthcare provider if you have any questions about how to prevent getting HIV infected or how to prevent spreading HIV to other people.

Do not use DapiRing

• If you are infected with HIV-1 or are unsure if you are infected with HIV-1. You must get tested to make sure that you do not already have HIV-1 infection. The DapiRing can only help to reduce the chance of you getting HIV-1 before you are infected.
• Some HIV tests may miss a recent infection in the early stages. If you get a flu-like illness, it could mean you have recently been infected with HIV. The following may be signs of HIV infection:
• tiredness
• fever
• joint or muscle pain
• headache
• vomiting or diarrhoea
• rash
• night sweats
• enlarged glands in the neck or groin
• Tell your healthcare provider about any flu-like illness – either in the month before starting to use the DapiRing, or at any time while using it.
• If you are allergic to dapivirine or any of the other ingredients of this product (listed in section 6).

Warnings and precautions

Talk to your healthcare provider before using the DapiRing. If you think you may have come into contact with HIV, tell your healthcare provider straight away. More tests may be needed to make sure you are still HIV negative. It is important to use the DapiRing all the time. Following the instructions on how to correctly use the DapiRing will reduce your chance of becoming HIV-1 infected:

• Always keep the ring in the vagina, especially during vaginal sex and also while you are having your period. Replace the ring 28 days with a new ring.
• Use the ring all the time, not just when you think you might be at risk of HIV-1 infection.
• If you take the ring out, you are no longer protected from HIV-1 infection.

Overall HIV infection prevention strategy

• Just using the DapiRing may not prevent you from becoming infected with HIV.
• Always practise safer sex to protect yourself from HIV infection.
• Use male or female condoms during sex to reduce contact with semen, vaginal fluids, or blood.
• Do not share personal items, such as razor blades, that can have blood on them.
• Do not share or re-use needles or other tools used for injecting medicines.
• Get tested for other sexually transmitted infections. These infections make it easier for HIV to infect you.

Ask your healthcare provider if you have any more questions about how to prevent getting HIV infected or spreading HIV to other people.

Risk associated with continued use of the ring, when infected

If you continue to use the ring while HIV-1 infected, the HIV-1 virus may undergo changes. These may lead to resistance of the virus and make it more difficult to treat with available anti-HIV treatments. It is important to get tested at least every 3 months for HIV infection.

No protection from HIV-1 infection other than through vaginal sex

The DapiRing only protects against HIV-1 infection during vaginal sex. It does not protect against HIV-1 infection which can happen from any activity other than vaginal sex, such as anal sex, oral sex and exposure to blood or sharp objects that may have been in contact with infected blood.

Use during menstruation

Leave the DapiRing in the vagina during your period. Contact with vaginal fluids, and blood during your period, may change the colour of the ring during use. Such discolouration does not affect the way the ring works. Tampons can be used at the same time as the vaginal ring. If using tampons, be careful when removing the tampon, to prevent accidentally pulling out the ring. Lower levels of the medicine (dapivirine) in the vagina were observed in some women during their period and with tampon use. It is unclear how this lower amount of medicine affects how well the ring works. As mentioned before, additional HIV prevention measures should always be used.

Vaginal practices

A healthy vagina cleans itself. Therefore, you should not use soap or other products to clean the inside of your vagina when using the DapiRing. You should not use any products to dry out your vagina for sex when using the DapiRing. These practices may affect how well the ring works to reduce your chance of getting HIV-1 infection.

Pelvic inflammatory disease and sexually transmitted or vaginal infections

The DapiRing does not protect you against vaginal infections or sexually transmitted infections, other than HIV-1 infection. The presence of these commonly occurring infections in your vagina may lead to swelling and pain and cause damage to the lining of your vagina. You may then be at a higher risk of getting HIV infection. These infections may also spread higher up in your vagina and cause a severe infection of your female organs higher up in your belly (pelvic region). It is important that you seek medical attention and treatment for these infections as soon as possible if you experience any symptoms such as itching, discomfort or pain in the vagina, a discharge from your vagina or severe pain in your lower belly.

Children and adolescents

The DapiRing is not for use in women under 18 years of age.

Other medicines and DapiRing

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your healthcare provider if you are taking, have recently taken or might take any other medicines or products that need to be put in your vagina. Ask your healthcare provider before using any of these medicines or products while you are still using the DapiRing.

Pregnancy, breastfeeding and fertility

The DapiRing does not prevent pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your healthcare provider for advice before using or continuing to use the DapiRing.

Driving and using machines

You can drive or operate machinery as long as you feel well.

Always use the ring exactly as your healthcare provider has told you. Check with your healthcare provider if you are not sure. Use only one DapiRing and replace it with a new ring every 28 days. Follow the next steps for insertion of the DapiRing:

Preparation

• Wash your hands in clean water and dry them.
• Remove the DapiRing from the package.

Positioning

Figure 1: Positioning for Inserting the DapiRing

A) B) C)

• Find a comfortable position for insertion of the DapiRing, this could be raising one leg, squatting or lying down (Figure 1A-C).

Insertion

Figure 2: Inserting the DapiRing

A) B) C)

• Hold the DapiRing between your thumb and index finger, twisting it into the shape of the number eight (8) or pressing the sides together (Figure 2A).
• Use the other hand to hold the folds of the skin around the vagina open.
• Place the tip of the vaginal ring into the vagina opening (Figure 2B).
• Use the index finger to gently push the folded vaginal ring into the vagina as far as possible (Figure 2C).
• If the ring feels uncomfortable, it may not have been pushed far enough into the vagina. Try again to gently push it into the vagina as far as possible, or remove and reinsert it. Please note: The ring cannot be pushed up too far or get lost in the body.
• If it still feels uncomfortable, contact your healthcare provider.
• Wash your hands in clean water and dry them.

Replacement

Figure 3: Removing the DapiRing

• Remove the vaginal ring 28 days from the day it was inserted.
• Wash your hands in clean water and dry them.
• Choose a comfortable position with legs apart.
• Use your finger to hook the vaginal ring and gently pull it out of your vagina (Figure 3).
• Immediately insert a new DapiRing, following the instructions for insertion (Figure 2).

Disposal

Figure 4: Disposing the used DapiRing

• Place the used vaginal ring inside an empty pouch (Figure 4) or wrap it in tissue or toilet paper.
• Dispose the used vaginal ring in the rubbish bin and out of reach of children.
• Do not dispose the vaginal ring in the toilet.
• Wash your hands in clean water and dry them.

If the DapiRing accidentally falls out or is removed

Your DapiRing may accidentally fall out e.g. when you go to the toilet or during vaginal intercourse, or be accidentally removed, e.g. when you remove a tampon. The woman may check if the DapiRing is still in the vagina if she is unsure whether it may have been accidentally expelled. She should follow the instructions for ring removal (Figure 3) to either remove the ring and immediately reinsert it (Figure 2) or choose a comfortable position and insert her index finger into the vagina to feel if the ring is still in place.

If this occurs in a place that is not dirty (e.g. in the bed or in the clothes):

• Rinse the DapiRing in clean water.
• Immediately re-insert the DapiRing as described above.

If the DapiRing has touched something dirty (e.g. the toilet):

• Do not re-insert the vaginal ring.
• Discard the vaginal ring as described above.
• Insert a new vaginal ring as described above.

If you use more DapiRing vaginal rings than you should

If you realise you have more than one ring in your vagina, remove all rings and insert a new ring immediately. Do not use any of the rings that you have just removed.

If you keep the ring in the vagina for longer than one month

If you realise that you have kept the ring in the vagina for longer than one month, replace with a new ring immediately.

If you forget to use DapiRing

Insert a new vaginal ring immediately. Do not insert two rings. Do not stop using DapiRing. While you are using the DapiRing, to reduce the chance of getting HIV-1 infected, do not stop or interrupt using the ring and do not miss any monthly ring replacements. Stopping the use of the ring, or missing the monthly replacement, may increase your chance of getting HIV-1 infection. Do not stop using the DapiRing without talking to your healthcare provider. If you have any further questions on the use of the DapiRing, ask your healthcare provider. If you remove the ring, your chance of getting HIV-1 infection is not reduced. You must talk to a healthcare provider if you have signs of HIV infection (listed in section 2) when using the DapiRing.

Not all side effects reported for the DapiRing are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using the DapiRing, please consult your health care provider for advice. If any of the following happens, stop using DapiRing and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DapiRing. You may need urgent medical attention or hospitalisation.

Tell your doctor as soon as possible if you notice any of the following:

Frequent side effects:

• Urinary tract infection
• Inflammation (swelling, redness and pain) of the vagina and/or the area outside the vagina (vulva),
• Inflammation of the lower part of the womb (cervix),
• Discharge from the vagina,
• Itching of the vagina and/or the area outside the vagina (vulva),
• Pain in the lower part of the belly (abdomen, pelvis),
• Pain or difficulty in passing urine.

Less frequent side effects:

• Inflammation of the bladder,
• Smell from the vagina,
• Redness or swelling of the lower part of the womb (cervix),
• An uncomfortable feeling of the vagina and/or the area outside the vagina (vulva),
• Pain in the vagina and/or the area outside the vagina (vulva),
• Discharge from the lower part of the womb (cervix),
• Bruising or small spots of internal bleeding of the lower part of the cervix,
• An uncomfortable feeling in the lowest part of the belly (pelvis),
• A sore (ulceration) in the vagina or the lower part of the womb (cervix),
• Passing of urine more often than normally,
• Pain in the bladder,
• Pain in the area below the belly button (navel),
• An uncomfortable feeling at the location where the ring is placed,
• A cut in the vagina,
• An uncomfortable feeling in the belly,
• An uncomfortable feeling or itching of the genitals,
• An area of the skin which is scraped away in the vulva (vulval abrasion),
• A feeling that you need to pass urine urgently,
• Pain at the location where the ring is placed.

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

Reporting of side effects

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

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original package in order to protect from light. Do not use if the seal on the pouch is broken. Do not open the package until the moment you are going to insert the DapiRing. Do not flush used or unused product. Do not throw away the DapiRing in the toilet or water drains. The used DapiRing should either be placed in an empty pouch or wrapped in tissue or toilet paper and disposed in the refuse bin, out of reach of children. Do not use after the expiry date printed on the label/carton. Return all expired or unused medicine to your pharmacist.