Description
Abacavir and lamivudine combination is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Abacavir and lamivudine combination will not cure or prevent HIV infection or the symptoms of AIDS. This medicine helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Abacavir and lamivudine combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV infection.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of abacavir and lamivudine tablets in children.
Appropriate studies have not been performed on the relationship of age to the effects of abacavir and lamivudine oral liquid in children younger than 3 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abacavir and lamivudine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving abacavir and lamivudine combination.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Atidarsagene Autotemcel
- Cabotegravir
- Horsetail
- Levoketoconazole
- Methadone
- Methotrexate
- Orlistat
- Ribavirin
- Sorbitol
- Tacrolimus
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Riociguat
- Tipranavir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diabetes or
- Heart disease or
- Hepatitis B, history of or
- Hepatitis C, history of or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Hypertension (high blood pressure) or
- Pancreatitis (swelling of the pancreas)—Use with caution. May make these conditions worse.
- Genetic condition (eg, gene variation called HLA-B*5701) or
- Kidney disease, severe or
- Liver disease, moderate or severe—Should not be used in patients with these conditions.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not start or stop using this medicine without checking first with your doctor.
This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine can be taken with or without food.
When your supply of this medicine runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to this medicine and be harder to treat.
To use the tablet for suspension:
- Do not use or take the tablet if it is damaged, broken, or expired.
- Place the tablets in the drinking cup. Then, add 2 teaspoons (10 mL) of drinking water for each tablet. Add 1 teaspoon (5 mL) of drinking water if you will use half of the tablet.
- Stir with a spoon or swirl the drinking cup for 2 to 3 minutes until the tablets break up into pieces small enough for a child to swallow.
- Do not chew the tablets or pieces of the tablets. Use the teaspoon to crush the pieces, if needed.
- Drink the mixture within 1 hour. If you do not drink the mixture right away after preparing, stir with a spoon or swirl the drinking cup again for 2 to 3 minutes before taking.
- Using an oral syringe: Place the tip of the syringe into the cup and draw all of the medicine up by pulling up on the plunger. Place the tip of the syringe against the inside of the child's cheek. Gently push down the plunger to give the dose slowly.
- Rinse the drinking cup with an additional small amount of water. Use about 1 to 2 teaspoons (5 to 10 mL) of drinking water for each tablet and drink or give all the mixture.
This medicine is given together with other medicines for HIV infection. Take all of the medicines your doctor gives you at the right time of day. These medicines work best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicines, check with your doctor.
Abacavir and lamivudine combination contains a fixed amount of each medicine in the tablet.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For HIV infection:
- For oral dosage form (tablets):
- Adults—One tablet once a day. Each tablet contains 600 milligrams (mg) of abacavir and 300 mg of lamivudine.
- Children weighing at least 25 kilograms (kg)—One tablet once a day.
- Children weighing less than 25 kg—Use and dose must be determined by your doctor.
- For oral dosage form (tablets for suspension):
- Children 3 months of age and older and weighing at least 5 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
- Weighing 35 kg or more—10 tablets (600 mg abacavir and 300 mg lamivudine) once a day or 5 tablets 2 times a day.
- Weighing 29 kg to less than 35 kg—8 tablets (480 mg abacavir and 240 mg lamivudine) once a day or 4 tablets 2 times a day.
- Weighing 25 kg to less than 29 kg—7 tablets (420 mg abacavir and 210 mg lamivudine) once a day or 3.5 tablets 2 times a day.
- Weighing 20 kg to less than 25 kg—6 tablets (360 mg abacavir and 180 mg lamivudine) once a day or 3 tablets 2 times a day.
- Weighing 17 kg to less than 20 kg—5 tablets (300 mg abacavir and 150 mg lamivudine) once a day or 2.5 tablets 2 times a day.
- Weighing 12 kg to less than 17 kg—4 tablets (240 mg abacavir and 120 mg lamivudine) once a day or 2 tablets 2 times a day.
- Weighing 9 kg to less than 12 kg—3 tablets (180 mg abacavir and 90 mg lamivudine) once a day or 1.5 tablets 2 times a day.
- Weighing 6 kg to less than 9 kg—2 tablets (120 mg abacavir and 60 mg lamivudine) once a day or 1 tablet 2 times a day.
- Weighing 5 kg to less than 6 kg—1 ½ tablets (90 mg abacavir and 45 mg lamivudine) once a day or ½ tablet taken in the morning and 1 tablet taken in the evening.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- Children 3 months of age and older and weighing at least 5 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
- For oral dosage form (tablets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away unused mixture within 1 hour.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause severe allergic reactions (including multi-organ failure) in some patients. This reaction usually occurs within 6 weeks after the medicine is started, but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Check with your doctor right away if you have sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, trouble breathing, sore throat, lightheadedness, dizziness, or yellow skin or eyes.
When you begin using this medicine, you will be given a Warning Card which describes symptoms of severe allergic reactions that may be caused by abacavir and lamivudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.
If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.
Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, have obesity, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping, dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.
Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder including Graves disease, polymyositis, or Guillain-Barré syndrome.
This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.
This medicine may increase your risk of having a heart attack. This is more likely to occur if you already have heart disease, high blood pressure, high cholesterol or fats in the blood, or if you smoke.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Cough
- diarrhea
- fever
- headache
- nausea
- numbness or tingling of the face, feet, or hands
- pain in the joints
- pain in the muscles
- skin rash
- sore throat
- stomach pain
- swelling of the feet or lower legs
- unusual feeling of discomfort or illness
- unusual tiredness or weakness
- vomiting
Incidence not known
- Blistering, peeling, or loosening of the skin
- bloating
- burning, numbness, tingling, or painful sensations
- chest pain
- chills
- constipation
- dark urine
- decreased appetite
- diarrhea
- difficulty with swallowing
- dizziness
- fast heartbeat
- fast, shallow breathing
- feeling of fullness
- general feeling of discomfort
- hives or welts, itching
- indigestion
- light-colored stools
- loss of appetite
- loss of bladder control
- muscle cramping
- muscle spasm or jerking of the arms and legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- redness of the skin
- red skin lesions, often with a purple center
- seizures
- sleepiness
- sores, ulcers, or white spots on the lips or in the mouth
- sudden loss of consciousness
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- troubled breathing with exertion
- unsteadiness or awkwardness
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- weakness in the arms, hands, legs, or feet
- yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abnormal dreams
- burning feeling in the chest or stomach
- fear or nervousness
- feeling of constant movement of self or surroundings
- lightheadedness
- sensation of spinning
- severe and throbbing headache
- stomach upset
- tenderness in the stomach area
- trouble sleeping
Incidence not known
- Abnormal breathing sounds
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- gaining weight around your neck, upper back, breast, face, or waist
- hair loss
- increased hunger
- increased thirst
- increased urination
- muscle weakness
- sweating
- swelling or inflammation of the mouth
- thinning of the hair
- unexplained weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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