Published: 6 August 2018
Revised: 23 January 2020
Safety Information
Monitoring Communication
Dolutegravir and the possible risk of neural tube defects when taken early in pregnancy
Original communication: 6 August 2018
Update: 23 January 2020
The sponsor of dolutegravir has updated Medsafe on this safety issue.
Further results have been received from the Tsepamo Study in Botswana. Since the initial 2018 report, the estimated prevalence has diminished in magnitude to approximately 3 per 1000 births but remains greater than for all other types of antiretroviral exposure at conception.
In view of the latest data and all other available data, the sponsor of dolutegravir has updated its recommendations for the use of dolutegravir-containing products as follows:
- Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir.
- WOCBP who are taking dolutegravir who are not planning pregnancy should be advised to use effective contraception throughout treatment.
- In WOCBP who are actively seeking to become pregnant, or if pregnancy is confirmed within the first trimester while on dolutegravir, the risks and benefits of continuing dolutegravir versus switching to another antiretroviral regimen should be assessed and switching to an alternative regimen should be considered.
- Dolutegravir should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
The sponsor of dolutegravir has written to healthcare professionals to provide further information about this issue (PDF 134 KB, 2 pages).
The consumer medicine information and data sheets have also been updated:
Consumer medicine information for Tivicay (PDF 56 KB, 5 Pages)
Data sheet for Tivicay (PDF 324 KB, 32 Pages)
Consumer medicine information for Triumeq (PDF 104 KB, 8 Pages)
Data sheet for Triumeq (PDF 236 KB, 37 Pages)
Original communication: 6 August 2018
Products Affected
Information for consumers
Information for healthcare professionals
Additional information
Regulator actions
Reporting
The sponsor of dolutegravir has informed Medsafe of a potential safety issue when this medicine is taken early in pregnancy.
Preliminary results of a study (the Tsepamo Study in Botswana) suggest a possible increased risk of neural tube defects in infants born to women who were taking dolutegravir at the time of conception. Neural tube defects (such as spina bifida) occur when the spinal cord fails to close during the development of the foetus. The study reported that 4 babies of 426 (0.9%) women who became pregnant while taking dolutegravir had a neural tube defect. In 11,173 women taking other medicines for HIV, 14 babies were born with a neural tube defect (0.1%). When women started taking dolutegravir later during pregnancy no babies were born with a neural tube defect.
Products Affected
Dolutegravir is used with other antiretroviral agents in the treatment of HIV infection in adults and children over 12 years of age.
There are two products containing dolutegravir approved for use in New Zealand:
- Tivicay (dolutegravir)
- Triumeq (dolutegravir, abacavir, lamivudine).
The Tivicay and Triumeq data sheets explain the effect on human pregnancy is unknown and that use in pregnancy should only be considered if the benefits to the mother outweigh the risks to the fetus.
Information for consumers
- If you are a woman taking dolutegravir, do not stop taking your medicine. Talk to your doctor if you have any concerns.
- If you are a women taking dolutegravir, use effective contraception.
- If you are planning to become pregnant and are taking dolutegravir, make a plan with your doctor before becoming pregnant.
- Tell your doctor right away if you become pregnant while taking dolutegravir.
Information for healthcare professionals
- In women of child bearing potential, pregnancy testing should be performed before initiating dolutegravir.
- Women of child bearing potential who are taking dolutegravir should avoid getting pregnant and should use effective contraception throughout treatment.
- Avoid using dolutegravir in women of child bearing potential who are trying to become pregnant unless a suitable alternative treatment option is not available.
- Switch to an alternative treatment regimen if pregnancy is confirmed in the first trimester while a woman is taking dolutegravir, unless there is not a suitable alternative treatment option available.
- Dolutegravir should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
- The sponsor of dolutegravir has written to healthcare professionals to provide further information about this issue. (PDF 87 KB, 3 Pages)
Additional information
Advice on how to take these medicines and the known side effects can be found in the consumer medicine information and data sheets:
Consumer medicine information for Tivicay (PDF 49 KB, 5 Pages)
Data sheet for Tivicay (PDF 258 KB, 31 Pages)
Consumer medicine information for Triumeq (PDF 91 KB, 8 Pages)
Data sheet for Triumeq (PDF 248 KB, 35 Pages)
The consumer medicine information and data sheets have been updated with information regarding this potential safety issue.
Regulator Actions
Medsafe, in conjunction with the sponsor, will continue to monitor this issue and will produce updated advice for healthcare professionals and consumers as necessary.
Reporting
Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking, Medsafe encourages you to talk to your healthcare professional.
