Product
Natazia
Approval Date
May 6, 2010
Release Date
July 8, 2010
Company
Bayer Corporation
Class
Estrogen + progestin
Indication
Oral contraception
Active Ingredient
Estradiol valerate + dienogest
Agency Roster
GSW (professional)
Ogilvy CommonHealth Worldwide (digital/direct-to-patient)
Y&R (consumer)
Ogilvy PR
Marketing Strategy/Execution
More contraceptive choices. That’s the message Bayer is stressing during the launch of Natazia, a novel oral contraceptive (OC) that’s the first to combine a synthetic estrogen and a progestin. The synthetic estrogen, estradiol valerate, is converted to the hormone estradiol in a woman’s body. All other combination OCs on the US market contain ethinyl estradiol. Natazia has been available in Europe as Qlaira since May 2009. The other promotional point to be stressed in marketing, Bayer said, is that Natazia delivers different doses of estradiol valerate (EV) and the progestin dienogest at different times during the cycle at the lowest effective doses of these hormones, making it an effective OC that may also give women shorter, lighter periods. Bayer is supporting Natazia’s launch through its field force and the Natazia.com website. Natazia is taken once a day, and the product has a distinctive dosing regimen, in which women take pills containing varying doses of EV, and EV plus dienogest, for specific days of the 28-day cycle.
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: Savvy vaginal gel
Manufacturer:Adamis Pharmaceuticals
Indication: Contraception
Active ingredient: C31G spermicide
Phase: III
Drug: NES/EE CVR vaginal ring
Manufacturer: Watson Pharmaceuticals
Indication: Contraception
Active ingredient: Ethinyl estradiol/elcometrine
Phase: III
Drug: E2/Nomac monophasic
Manufacturer: Merck
Indication: Contraception
Active ingredient: Estradiol/nomegestrol monophasic
Phase: III
Drug: DR 1021
Manufacturer: Teva Pharmaceutical Industries
Indication: Contraception
Active ingredient: Ethinylestradiol/desogestrel
Phase: III
Drug: BAY86-5016
Manufacturer: Bayer Schering Pharma
Indication: Contraception
Active ingredient: Ethinylestradiol/gestodene transdermal
Phase: III
Drug: AG 20015
Manufacturer: Agile Therapeutics
Indication: Contraception
Active ingredient: Ethinylestradiol/levonorgestrel transdermal
Phase: III
Drug: G04209C
Manufacturer: Bayer Schering Pharma
Indication: Contraception
Active ingredient: Levonorgestrel intrauterine ultra low-dose
Phase: III
Drug: WC3016
Manufacturer: Warner Chilcott
Indication: Contraception
Phase: Preregistration
Drug: WC3026
Manufacturer: Warner Chilcott
Indication: Contraception
Phase: Preregistration
Source: Wolters Kluwer Pharma Solutions
Adverse Reactions
Headache, irregular uterine bleeding, mastodynia, GI upset, acne, increased weight; hypertension, transient delay of ovulation after discontinuation, edema, chloasma. Increased risk of gallbladder disease, thromboembolic disorders.
Adults
BMI >30kg/m2: insufficient data. 1 tab daily for 28 days; repeat. Use Day 1 start; use non-hormonal backup method for first 9 days. Do not skip doses or delay dose >12 hours. Switching from other methods: see literature.
Children
Not recommended.
Precautions
Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Diabetes. Prediabetes. Depression. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Nursing mothers: not recommended.
Interactions
May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate) (use backup contraception). May be affected by protease inhibitors. May antagonize lamotrigine. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.
Contradictions
High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy (Cat. X).
