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warnings
WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.
ADVERSE REACTIONS Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone ® 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3. TABLE 3 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Crinone® 8% Twice Daily Study COL1620-007US (n=61) Body as a Whole Bloating 7% Cramps NOS 15% Pain 8% Central and Peripheral Nervous System Dizziness 5% Headache 13% Gastro-Intestinal System Nausea 7% Reproductive, Female Breast Pain 13% Moniliasis Genital 5% Vaginal Discharge 7% Skin and Appendages Pruritus Genital 5% In a second clinical study of 139 women using Crinone ® 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in ≥5% of the women are shown in Table 4. TABLE 4 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Crinone® 8% Once Daily Study COL1620-F01 (n=139) Body as a Whole Abdominal Pain 12% Perineal Pain Female 17% Central and Peripheral Nervous System Headache 17% Gastro-Intestinal System Constipation 27% Diarrhea 8% Nausea 22% Vomiting 5% Musculo-Skeletal System Arthralgia 8% Psychiatric Depression 11% Libido Decreased 10% Nervousness 16% Somnolence 27% Reproductive, Female Breast Enlargement 40% Dyspareunia 6% Urinary System Nocturia 13% Secondary Amenorrhea In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone ® 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Crinone ® treatment that occurred in 5% or more of women are shown in Table 5. TABLE 5 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Estrogen Treatment and Crinone® Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US Estrogen + Crinone® 4% n=62 Estrogen + Crinone® 8% n=65 Body as a Whole Abdominal Pain 3 (5%) 6 (9%) Appetite Increased 3 (5%) 5 (8%) Bloating 8 (13%) 8 (12%) Cramps NOS 12 (19%) 17 (26%) Fatigue 13 (21%) 14 (22%) Central and Peripheral Nervous System Headache 12 (19%) 10 (15%) Gastro-Intestinal System Nausea 5 (8%) 4 (6%) Musculo-Skeletal System Back Pain 5 (8%) 2 (3%) Myalgia 5(8%) 0(0%) Psychiatric Depression 12 (19%) 10 (15%) Emotional Lability 14 (23%) 14 (22%) Sleep Disorder 11 (18%) 12 (18%) Reproductive, Female Vaginal Discharge 7 (11%) 2 (3%) Resistance Mechanism Upper Respiratory Tract Infection 3 (5%) 5 (8%) Skin and Appendages Pruitis genital 1 (2%) 4 (6%) Additional adverse events reported in women at a frequency <5% in Crinone ® ART and secondary amenorrhea studies and not listed in the tables above include: Autonomic Nervous System–mouth dry, sweating increased Body as a Whole–abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia Cardiovascular, General–syncope Central and Peripheral Nervous System–migraine, tremor Gastro-Intestinal–dyspepsia, eructation, flatulence, gastritis, toothache Metabolic and Nutritional–thirst Musculo-Skeletal System–cramps legs, leg pain, skeletal pain Neoplasm–benign cyst Platelet, Bleeding & Clotting–purpura Psychiatric–aggressive reactions, forgetfulness, insomnia Red Blood Cell–anemia Reproductive, Female–dysmenorrhea, premenstrual tension, vaginal dryness Resistance Mechanism–infection, pharyngitis, sinusitis, urinary tract infection Respiratory System–asthma, dyspnea, hyperventilation, rhinitis Skin and Appendages–acne, pruritis, rash, seborrhea, skin discoloration, skin disorder, urticaria Urinary System–cystitis, dysuria, micturition frequency Vision Disorders–conjunctivitis