Dolutegravir (Oral)

Dolutegravir is a drug that is used to help manage the symptoms of human immunodeficiency virus (HIV) and slow down its progression.

Overview

In the US, dolutegravir is known by the brand name, Tivicay. The drug is used with other medications to help manage the symptoms of human immunodeficiency virus (HIV). HIV ultimately causes the potentially fatal condition, acquired immune deficiency syndrome (AIDS) in some patients.

Dolutegravir is one of a group of drugs called integrase inhibitors.

This medicine will not cure HIV or AIDS, nor will it stop you from catching the diseases or spreading HIV to other people. Dolutegravir is designed to prevent the virus from spreading within your body and can help to slow down the damage that it causes to your immune system. Even though dolutegravir is very effective, you may still continue to suffer from some of the health issues that HIV and AIDS cause.

Dolutegravir is only available via prescription from your doctor and comes in tablet form.

Conditions treated

  • Human immunodeficiency virus (HIV)
  • Acquired immune deficiency syndrome (AIDS)

Type of medicine

  • Tablet
  • Integrase inhibitor

Side effects

In addition to the effects it is designed to deliver, some drugs can cause unwanted side effects. Not all these effects will affect every patient, but if they do occur, you may have to seek further medical advice. If you notice any of the effects in the bulleted list below, contact your doctor for immediate advice:

  • Jaundice
  • Unexpected weight gain
  • Upper right stomach or abdominal pains
  • Unusual weakness or tiredness
  • Unusual bruising or bleeding
  • Breathing problems
  • Swollen glands
  • Swelling of the lower legs, fingers or face
  • White spots, sores, or ulcers around the mouth or lips
  • Sore throat
  • Severe rash
  • Pain, redness, swelling of the eyes, or eyelids
  • A rash accompanied by fever
  • Painful or difficult urination
  • Nausea and vomiting
  • Joint or muscle aches
  • Lower back or side pain
  • Loss of appetite
  • Pale-colored stools
  • Large, flat swellings on the eyelids, face, tongue, lips, throat, legs, hands, genitals or feet
  • Increased thirst
  • Feeling generally weak or tired
  • A general feeling of being unwell or in discomfort
  • Fever
  • Discharge or excessive tearing of the eyes
  • Decreased frequency or amount of urine
  • Dark urine
  • Cough
  • Chills
  • Chest pain
  • Dry, burning, or itching eyes
  • Bloody urine
  • Blistering or peeling skin
  • Black, tarry stools

There are some side effects of dolutegravir that do not generally need further medical attention. These effects often resolve by themselves as your body gets used to the new drug. Your GP may also be able to recommend ways in which you can prevent or manage some of the side effects. You should ask your treating physician if any of the effects noted below continue for more than a week or two or prove especially troublesome:

  • Gaining weight, especially on your upper back, neck, breast, waist or face
  • Insomnia
  • Itchy skin
  • Headaches
  • Dizziness
  • Diarrhea
  • Abnormal dreams
  • Stomach or abdominal discomfort of pain

Not every side effect reported by people taking dolutegravir is listed here. You should talk to your GP if you notice any other effects while using this drug.

Dosage

You should take this drug precisely as it is prescribed to you by your GP. Do not take extra, do not take it more frequently, and do not continue taking it for a longer period than you have been told to. It is important that you do not alter the dose or cease using the medication, without asking your doctor first. When you notice that your supply of dolutegravir is getting low, ask your GP or pharmacist in good time for a repeat prescription. Do not allow your medication to run out completely.

When you are given your supply of dolutegravir, you will also be given a patient information leaflet. Read the information contained in the insert, and ask your pharmacist or GP if you have any questions.

You must take the full course of dolutegravir, even if you think your condition is improving. The medication is most effective when taken in conjunction with other HIV medicines. Take all of the medication you have been given by your treating physician, and be sure to take them at the right times.

You can take dolutegravir with water or with food, as preferred.

You must take your dose of dolutegravir at least two hours before or six hours after taking any laxatives or antacid drugs that contain calcium, aluminum, magnesium, iron, sucralfate or buffered medications. You may take calcium and iron supplements at the same time as dolutegravir, provided you are eating a meal.

The dose of dolutegravir that you are told to take will not necessarily be the same as for other people. You must adhere to the directions that your doctor has given you, or follow the instructions that are contained on the dispensary label. The dosage levels shown in this guide are purely based on the average. If your dose is at variance with this, do not change it, unless you are instructed to do so by your GP.

Your personal dosage level will vary depending on the strength of the tablets you are given. In addition, the quantity of dolutegravir, the number of daily doses, time lapse between tablets, and the total length of your course will depend on your medical condition.

For the treatment of HIV

  • Adults: Daily dose is 50 mg. If you are already on other HIV medication, take 50 mg twice daily.
  • Children: Children over 40 kg in weight should take 50 mg once daily.
  • Children: Children 30 kg to under 40 kg in weight should take 35 mg once daily (1 x 25 mg tablet and 1 x 10 mg tablet).
  • Children: Children under 30 kg in weight your GP will calculate the appropriate dose.

In the event that you forget to take a dose of dolutegravir, you must try to take it as quickly as possible. If it is less than four hours till your next due dose, leave out the one you have missed and revert to your usual dosage schedule.

Never take twice the dose to try to catch up on missed tablets.

Interactions

There are some drugs that must never be used together, as doing so could cause an interaction to take place. However, sometimes your doctor may direct you to use two or more drugs at the same time, although the dose or frequency of use may be altered. Before you start using dolutegravir, you must tell your doctor if you are already taking any of the drugs that are listed below.

You must not take dolutegravir with the medication, dofetilide. Your doctor may take you off this medicine or change some of the other drugs you are taking.

It is not recommended that you use dolutegravir with any of the following medicines. But if it is deemed to be the best treatment option for you, your doctor may change some of the drugs or alter the dose:

  • Tipranavir
  • St John's Wort
  • Rifapentine
  • Rifampin
  • Primidone
  • Phenytoin
  • Oxcarbazepine
  • Nevirapine
  • Metformin
  • Fosphenytoin
  • Fosamprenavir
  • Etravirine
  • Eslicarbazepine Acetate
  • Enzalutamide
  • Efavirenz
  • Dasabuvir
  • Dabrafenib
  • Carbamazepine
  • Amprenavir

Taking dolutegravir with any of the drugs in the bulleted list below is not a good idea, as doing so could cause an increased danger of side effects. However, if your doctor decides that this is the best option for you, he may change your dose or frequency of use of one or both of the drugs:

  • Zinc
  • Sucralfate
  • Magnesium
  • Magaldrate
  • Iron
  • Calcium
  • Aluminum

Some types of foodstuffs should not be used at the same time as using certain forms of drugs. In addition, you should not use alcohol or tobacco with some drugs. Before you begin using dolutegravir, have a chat with your GP about your use of alcohol or tobacco, and also mention any preferred food groups that you tend to eat a lot of.

Medical history

Some existing or historical medical conditions can affect how this medication works. You must have a full and frank discussion with your GP about your medical history before you begin using dolutegravir.

Using dolutegravir if you have ever suffered from hepatitis B or C should be avoided, as doing so could make these conditions worse.

Dolutegravir can depress your immune system, making it more difficult for your body to fight off infections. Do not take this medication if you have a chronic infection.

Dolutegravir is not recommended for patients who are suffering from severe liver disease.

Warnings

When you decide to begin taking a particular drug, you should talk to your doctor about the risks and benefits of doing so and make a decision based on that discussion.

If you are allergic to dolutegravir, or to any other prescription or over the counter medication, you must tell your GP. You should also mention any allergies that you have to food colors, preservatives, certain food groups and animal products.

You should not take any other form of medication unless your doctor approves it first. This includes herbal remedies, over the counter medication, and vitamin supplements.

It is not known whether it is safe to use dolutegravir in children weighing less than 30 kgs, although this drug is not generally prescribed in these circumstances.

Dolutegravir should not be used in elderly patients who present a high risk of side effects because they already have heart, liver or kidney problems.

Pregnancy and breastfeeding

It is not known whether this drug can present a risk to the unborn baby. If you are pregnant or if you are considering getting pregnant while you are being treated with this drug, you should mention this to your doctor. Deliberately getting pregnant if you are suffering from HIV is not very responsible, as the baby has a high risk of being born HIV positive, potentially leading to lifelong complications.

No adequate studies have been carried out to show whether dolutegravir passes into breast milk. However, if you are breastfeeding, you should discuss the risks and benefits of continuing to do so with your doctor or midwife. It may be better to use an alternative way of feeding for your infant until you have finished taking this drug.

Check-up appointments

Regular check-ups are very important during the course of your treatment with this drug. You may also be asked to have blood tests in order to make sure that the medication is working correctly and is not causing any unwanted effects.

Serious effects

Using this medication with dofetilide (Tikosyn®) can cause very serious side effects, which may be life-threatening.

Some people suffer a very serious side effect when they begin using this medicine. If you experience any of the following effects, stop taking the drug and consult your GP immediately:

  • Severe rash
  • Rash accompanied by fever
  • Peeling or blistering of the skin
  • Pain in the joints or muscles
  • Sores in the mouth
  • Facial swelling
  • Breathing difficulties
  • Feeling very weak or tired
  • Jaundice

Some people experience weight gain when they begin using this medication. You should mention to your doctor if you notice your body changing shape, especially if you start to get fatter on your upper back, neck, stomach or chest. Conversely, you might begin to shed fat from around your legs, face, or arms.

Dolutegravir can cause some people to develop a stronger immune system when they first start taking it. You must inform your doctor right away if you notice any changes in your general health. This means that if you have a hidden infection in your body, including TB, pneumonia, polymyositis, Graves' disease, or Guillain-Barré syndrome, you may not realise that you have the condition.

Safe sex

Dolutegravir will not prevent you from passing HIV to someone else during sex. Ask your GP for advice on how to practice safe sex, even if your regular partner also has HIV. Always use a latex condom or some other form of barrier protection. Never share needles with other people or re-use your own needles.

Do not share toothbrushes, razors or any other items that might pass your blood or other bodily fluids to others.

Storage

You should keep your supply of dolutegravir out of reach of small children and pets. If a pet accidentally consumes any of your tablets, consult your emergency vet immediately.

Be sure to store the tablets in their original closed container and away from direct sources of heat. Keep the medicine out of direct sunlight. Do not freeze or refrigerate the tablets. Do not allow the tablets to get damp.

Do not use tablets that are out of date or that appear to be cracked or damaged. Dispose of unwanted tablets correctly by placing them in a sealed bag and putting them at the bottom of your trash can where they cannot be found by children or animals. Alternatively, take any unwanted medication to your pharmacist or doctor for safe disposal.

Summary

Dolutegravir is a prescription medication that is used to treat HIV. The drug is an integrase inhibitor and works by stopping the HIV virus from spreading, slowing the development of the disease into full-blown AIDS, and boosting your immune system. The medicine cannot cure HIV or AIDS, and it will not stop you from spreading the disease to other people.

There are a number of medicines and existing medical conditions that make the use of dolutegravir inappropriate. You should discuss your medical history in full with your GP before you begin using this drug. You will also need to attend for regular check-ups and blood tests to make sure that the medication is working effectively and that it is not causing any unwanted side effects.