Enrollment

REBETOL®
(ribavirin)
CRIXIVAN®
(indinavir sulfate)
ISENTRESS®
(raltegravir)
GARDASIL®
[Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine]
GARDASIL®9
[human papillomavirus 9-valent vaccine, recombinant]
JANUVIA®
(sitagliptin phosphate)
JANUMET®
(sitagliptin/metformin HCl)
MAXALT®
(rizatriptan benzoate)
SINGULAIR®
(montelukast sodium)
VARICELLA ZOSTER VIRUS-CONTAINING VACCINES


 

The Pregnancy Registry for JANUVIA and JANUMET receives voluntary reports from healthcare providers or from women/family members/friends about women who inadvertently (before knowing they were pregnant) or purposefully (knowingly took the drug to control their diabetes) used JANUVIA or JANUMET during pregnancy. The women are enrolled and their pregnancies are followed. Outcomes are obtained from participating clinicians.

The limited available data with JANUVIA and JANUMET in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk.

Sitagliptin Phosphate
In embryo-fetal development studies, sitagliptin administered to pregnant rats and rabbits during organogenesis (gestation day 6 to 20) did not adversely affect developmental outcomes at oral doses up to 250 mg/kg (30-times the 100 mg clinical dose) and 125 mg/kg (20-times the 100 mg clinical dose), respectively, based on AUC. Higher doses in rats associated with maternal toxicity increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100-times the clinical dose, based on AUC. Placental transfer of sitagliptin was observed in pregnant rats and rabbits. Sitagliptin administered to female rats from gestation day 6 to lactation day 21 caused no functional or behavioral toxicity in offspring of rats at doses up to 1000 mg/kg.

Metformin hydrochloride
No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during organogenesis at doses up to 2- and 6-times, respectively, a 2000 mg clinical dose, based on body surface area.

Literature Review

In the US, as of 2018, 34.1 million adults aged 18 years or older—or 13.0% of all US adults—had diabetes.1 As specified in the Prescription Drug Labeling, the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has been reported to be as high as 20-25% in women with a Hemoglobin A1c >10%. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Enrollment

Healthcare providers are encouraged to report cases of prenatal exposure as early in pregnancy as possible to facilitate the collection of prospective, unbiased information. Enroll your patient by completing the simple 1-page enrollment form available under download forms. You will be asked to complete a second 1-page Outcome of Pregnancy form at the end of the pregnancy. We provide you with a 1-page patient consent form that explains the Pregnancy Registry to your patient. We encourage you to review it with your patient and have her sign it before the end of her pregnancy. All forms can be faxed (or mailed) to the Pregnancy Registry.

Criteria for enrollment include:

  1. A report of pregnancy from a patient or healthcare provider (US residents only)
  2. Exposure to JANUVIA or JANUMET during pregnancy (any time after the woman's last menstrual period)
  3. Name of a healthcare provider (to confirm diagnoses and to obtain outcome information)
  4. Name of the patient or, if you wish to keep the report confidential, patient initials and one other patient identifier, such as date of birth or chart number, to allow for follow-up at expected date of delivery

Information from the Registry is used to respond to inquiries from healthcare providers who call to request information on the use of a product during pregnancy. Data may be published or used to update the pregnancy section of the product label, as appropriate. Dissemination of data collected in the Registry is done without compromising individual patient confidentiality. Information from the Registry is shared, as required, with regulatory authorities (eg, the FDA).

Annual Reports

Reports of the aggregate data in the Registry are updated annually and are available to healthcare providers in the United States upon request. (In countries outside the United States, information is available through the local Merck subsidiary). To request a report, call the toll-free number below or download and complete the attached Annual Report Request Form and fax it to the Registry. Please include your fax number. A report will be sent to you within 3 business days.

Pregnancy Registry for JANUVIA and JANUMET
1-800-986-8999

(FAX) 215-661-6229

References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2020. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf



 


Enrollment form for JANUVIA and JANUMET
Patient consent form for JANUVIA and JANUMET
Spanish patient consent form for JANUVIA and JANUMET
Request for the Annual Report form for JANUVIA and JANUMET
Package insert for JANUVIA
Patient package insert for JANUVIA
Package insert for JANUMET
Patient package insert for JANUMET


Or call 1-800-986-8999 to enroll a patient, report an outcome of pregnancy, request an annual report, or request any of the above forms.


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