Sustiva

What Sustiva is and what it is used for

SUSTIVA, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood. It is used by adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg. Your doctor has prescribed SUSTIVA for you because you have HIV infection. SUSTIVA taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood. This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection

How to take Sustiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will give you instructions for proper dosing. ▪ The dose for adults is 600 mg once daily. 6 ▪ The dose for SUSTIVA may need to be increased or decreased if you are also taking certain medicines (see Other medicines and SUSTIVA).SUSTIVA is for oral use. SUSTIVA is recommended to be taken on an empty stomach preferably at bedtime. This may make some side effects (for example, dizziness, drowsiness) less troublesome. An empty stomach is commonly defined as 1 hour before or 2 hours after a meal. ▪ It is recommended that the capsule be swallowed whole with water. ▪ SUSTIVA must be taken every day. ▪ SUSTIVA should never be used alone to treat HIV. SUSTIVA must always be taken in combination with other anti-HIV medicines. Use in children and adolescents ▪ SUSTIVA hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules. Opening the capsule and taking the contents with a small amount of food may be considered for children who cannot swallow the hard capsule. ▪ The dose for children and adolescents is calculated by body weight and is taken once daily as shown below: Body Weight SUSTIVA Number of Capsules or Tablets and Strength to Administer kg Dose (mg) 3.5 to < 5 100 one 100 mg capsule 5 to < 7.5 150 one 100 mg capsule + one 50 mg capsule 7.5 to < 15 200 one 200 mg capsule 15 to < 20 250 one 200 mg capsule + one 50 mg capsule 20 to < 25 300 three 100 mg capsules 25 to < 32.5 350 three 100 mg capsules + one 50 mg capsule 32.5 to < 40 400 two 200 mg capsules ≥ 40 600 one 600 mg tablet OR three 200 mg capsules For children who are not able to swallow the capsules, the doctor may recommend opening the hard capsule and mixing the contents with a small amount (1-2 teaspoons) of food (e.g., yogurt ). The capsules must be opened carefully so that the contents do not spill or escape into the air. Hold the capsule with the cap facing up and pull the cap away from the body of the capsule. Use a small container for mixing. Give the mixture to the child as soon as possible, but no more than 30 minutes after mixing. Make sure the child eats the full amount of the mixture of food and capsule contents. Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container, stirring to make sure there is no drug residue remaining in the container, and have the child eat the full amount again. The child should not be given any additional food for 2 hours. The doctor may also recommend this method of taking SUSTIVA for adults who cannot swallow capsules. Instructions for capsule sprinkle method: 1 Avoid giving the daily SUSTIVA dose within 1 hour after a feeding or meal. 2 Wash and dry your hands before and after preparing the capsule sprinkle. 3 Choose a soft food the child likes. Examples of soft foods are applesauce, grape jelly, yogurt, or infant formula. In a taste preference study in adults, SUSTIVA mixed with grape jelly received the best rating. 7 4 Place 1-2 teaspoons of the food in a small container (illustration a). 5 SUSTIVA capsules must be opened carefully over the food container, as described in steps 6-7, so that the contents do not spill. 6 With your hands over the container, hold the capsule with the cap facing up (see illustration b). 7 Carefully pull the cap away from the body of the capsule (illustration c). 8 Sprinkle the contents of the capsule on the food (illustration d). 9 If the daily dose consists of more than one capsule, follow steps 5-8 for each capsule. Do not add more food. 10 Mix the capsule contents and food together (illustration e). Steps 11-14 must be completed within 30 minutes of mixing: 11 Give the mixture of food and capsule contents to the child, making sure he or she eats the full amount (illustration f). 12 Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container (illustration a). 13 Stir to make sure there is no drug residue remaining in the container (illustration e). 14 Have the child eat the full amount again (illustration f). 15 Do not give the child any additional food for 2 hours. If you take more SUSTIVA than you should If you take too much SUSTIVA contact your doctor or nearest emergency department for advice. Keep the medicine container with you so that you can easily describe what you have taken. If you forget to take SUSTIVA Try not to miss a dose. If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose. If you need help in planning the best times to take your medicine, ask your doctor or pharmacist. 8 If you stop taking SUSTIVA When your SUSTIVA supply starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself. During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. The most notable unwanted effects reported with SUSTIVA in combination with other anti-HIV medicines are skin rash and nervous system symptoms. You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA. Rash was more common in children than in adults treated with SUSTIVA. The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks. In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose. If you are affected your doctor may suggest that you take SUSTIVA at bedtime and on an empty stomach. Some patients have more serious symptoms that may affect mood or the ability to think clearly. Some patients have actually committed suicide. These problems tend to occur more often in those who have a history of mental illness. Always notify your doctor immediately if you have these symptoms or any side effects while taking SUSTIVA. Tell your doctor if you notice any of the following side effects:

Very common (affects more than 1 user in 10)
•skin rash

Common (affects 1 to 10 users in 100)
•abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination or balance
•stomach pain, diarrhoea, feeling sick (nausea), vomiting
•itching
•tiredness
•feeling anxious, feeling depressed Tests may show:
•increased liver enzymes in the blood
•increased trigycerides (fatty acids) in the blood

Uncommon (affects 1 to 10 users in 1,000)
•nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts
•blurred vision
•a feeling of spinning or tilting (vertigo)
•pain in the abdomen (stomach) caused by inflammation of the pancreas 9
•allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
•yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
•breast enlargement in males
•angry behaviour, mood being affected, seeing or hearing things that are not really there (hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period)
•whistling, ringing or other persistent noise in the ears
•tremor (shaking)
•flushing Tests may show:
•increased cholesterol in the blood

Rare (affects 1 to 10 users in 10,000)
•itchy rash caused by a reaction to sunlight
•liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz. Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease.
•unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly
•suicide

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

How to Store Sustiva

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle or blister and on the carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.