Tivicay (Dolutegravir Sodium)
(℞) Prescription required. Can not be split. Product of Canada. Shipped from Canada.
To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. read more
Dolutegravir Sodium Information
(doe'' loo teg' ra vir)[Posted 05/18/2018] AUDIENCE: Infectious Disease, Health Professional, Patient ISSUE: Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects. Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. We are investigating this new safety issue and will update the public when we have more information. BACKGROUND: Dolutegravir is an FDA-approved antiretroviral medicine used in combination with other antiretroviral medicines to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Dolutegravir works by blocking integrase, an HIV enzyme, to prevent the virus from multiplying and can reduce the amount of HIV in the body. Stopping dolutegravir without first talking to a prescriber can cause the HIV infection to become worse. Approved in 2013, dolutegravir has been on the market for 5 years, and is available as a single ingredient product under the brand name Tivicay and as a fixed dose combination tablet with other HIV medicines under the brand names Juluca and Triumeq. RECOMMENDATION: Patients should not stop taking dolutegravir without first talking to your health care professional because stopping your medicine can cause the HIV infection to worsen. In addition:
- If you are already pregnant, stopping your dolutegravir-containing regimen without switching to alternative HIV medicines could cause the amount of virus to increase and spread HIV to your baby.
- If you take a dolutegravir-containing regimen at the time of becoming pregnant and during the first trimester of pregnancy, there is a risk that your baby may develop neural tube defects. Neural tube defects happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their health care professional about other non-dolutegravir-containing antiretroviral medicines.
- You should tell your health care professional if you are pregnant or are planning to become pregnant before you start a dolutegravir-containing regimen. Your health care professional may discuss other treatment options with you.
- Women of childbearing age who decide to take a dolutegravir-containing regimen should consistently use effective birth control (contraception) while on HIV treatment. Women should talk to their health care professionals about an effective birth control method to use while taking a dolutegravir-containing regimen.
- Before you start a dolutegravir-containing regimen you will need a pregnancy test to determine if you are already pregnant.
- Healthcare professionals should weigh the benefits and the risks of dolutegravir when prescribing antiretroviral medicines to women of childbearing age. Alternative antiretroviral medicines should be considered. Discuss the relative risks and benefits of appropriate alternative antiretroviral therapies.
- If the decision is made to use dolutegravir in women of childbearing age, health care professionals should reinforce the consistent use of effective birth control.
- Perform pregnancy testing before initiating a dolutegravir-containing regimen in women of childbearing age to exclude pregnancy.
Before taking dolutegravir,
- tell your doctor and pharmacist if you are allergic to dolutegravir, any other medications, or any of the ingredients in dolutegravir tablets. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
- tell your doctor if you are taking dofetilide (Tikosyn). Your doctor will probably tell you not to take dolutegravir if you are taking this medication.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins ,and nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: other medications for HIV including efavirenz (Sustiva, in Atripla), etravirine (Intelence), fosamprenavir (Lexiva) taken with ritonavir (Norvir), nevirapine (Viramune), and tipranavir (Aptivus) taken with ritonavir (Norvir); certain medications for seizures including carbamazepine (Carbatrol, Equetro, Tegretol), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); metformin (Fortomet, Glumetza, Glucophage, Riomet); and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking antacids or laxatives that contain aluminum, magnesium, or calcium; calcium supplements; iron supplements; sucralfate (Carafate); or buffered medications such as buffered aspirin, take them 2 hours after or 6 hours before you take dolutegravir.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have or have ever had kidney disease or liver disease including hepatitis B or hepatitis C.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking dolutegravir, call your doctor. Also tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking dolutegravir.
- you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.
- you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms after starting treatment with dolutegravir, be sure to tell your doctor.
- difficulty falling asleep or staying asleep
- stomach pain
- feeling sick
- excessive tiredness
- muscle or joint pain
- blistering or peeling skin
- blisters or sores in the mouth
- red or swollen eyes
- swelling of the eyes, face, lips, mouth, tongue, or throat
- difficulty breathing or swallowing
- dark urine
- pale colored bowel movements
- loss of appetite
- pain in the upper right part of the stomach