Page 2 - FSANZ UPDATE Spring 2022

PBS listed for
ART*
-Authorityrequired(streamlined) 4997
200mg daily up to 400mg twice a day
Convenient for patients... no lunch time dose
Prevention of preterm birth*
- Authority required (streamlined) 11673
200mg daily from 16 weeks gestation continued until delivery
Halal Vegan
ORIPRO
HOW TO USE VIDEO
Plant based
*For full PBS eligibility information please visit www.pbs.gov.au
Natural micronised progesterone pessary
Scan the QR code to view and can save the link to your browser!
*ORIPRO® is indicated for (1) Assisted Reproductive Technology (ART) treatment of infertile women with progesterone deficiency, requiring progesterone supplementation or replacement to support embryo implantation and maintain initial pregnancy, (2) Prevention of preterm birth in singleton pregnancies at risk due to; shortened cervix (midtrimester sonographic cervix ≤25mm) and/or where there is a history of spontaneous preterm birth.
PLEASE REVIEW FULL PRODUCT INFORMATION (PI) BEFORE RECOMMENDING.
THE FULL PI IS AVAILABLE FROM PERRIGO AUSTRALIA UPON REQUEST (FREECALL: 1800 805 546).
MINIMUM PRODUCT INFORMATION: ORIPRO® (progesterone) 100mg and 200mg pessaries. INDICATIONS: ORIPRO® is indicated for (1) Assisted reproductive technology (ART) treatment of infertile women with progesterone deficiency, requiring progesterone supplementation or replacement to support embryo implantation and maintain initial pregnancy, (2) Prevention of preterm birth in singleton pregnancies at risk due to; shortened cervix (midtrimester sonographic cervix ≤25mm) and/or where there is a history of spontaneous preterm birth. CONTRAINDICATIONS: Sensitivity to progesterone, sensitivity to hard fat, undiagnosed vaginal bleeding, undiagnosed urinary tract bleeding, liver dysfunction or disease, active thrombophlebitis or thromboembolic disorder (deep vein thrombosis, pulmonary embolism) or a history of hormone associated thrombophlebitis or thromboembolic disorder, known or suspected malignancy of the breast or genital organs, missed abortion or ectopic pregnancy. Progesterone is contraindicated in pregnancy during assisted reproductive technology (ART) treatment, when normal progesterone levels are present. PRECAUTIONS: Before initiation or recommencing progesterone therapy in women, a physical examination should be performed, including special attention to the breasts, abdomen and pelvic organs and a Papanicolaou (Pap) smear. See full PI for Precautions. INTERACTIONS: Please refer to the product information for interactions with other drugs. SIDE EFFECTS: Incidence more frequent; Reproductive, Female: Amenorrhoea, abnormal breakthrough uterine bleeding or metromenorrhagia, spotting, changes in cervical eversion and secretions. Metabolic and Nutritional: Hyperglycaemia (dry mouth, frequent urination, loss of appetite, unusual thirst). Incidence less frequent; Reproductive, Female: Galactorrhoea. Psychiatric: Mental depression. Skin and Appendages: Skin rash, Pruritus. Incidence rare; Endocrine: Adrenal suppression or insufficiency (causing symptoms of dizziness, nausea or vomiting, unusual tiredness or weakness). Circulatory System: Thromboembolism or thrombus formation (causing headache or migraine, loss of or change of speech, coordination or vision, pain or numbness in chest, arm or leg; unexplained shortness of breath). Other adverse reactions - See full PI for complete list. DOSAGE AND ADMINISTRATION: Assisted Reproductive Technology (ART): The usual dose of progesterone to support embryo implantation and maintain pregnancy, preventing miscarriage due to progesterone deficiency is 200mg daily to a maximum of 400 mg twice a day. The dosage in corpus luteum insufficiency is 100 mg one to two times a day initiated within several days of ovulation. Prevention of Preterm Birth: The dosage of progesterone for prevention of preterm birth is 200 mg daily (at night). Treatment can be initiated during the second trimester (16-24 weeks gestation) and is to be continued to the end of the 36th week of gestation or until delivery. See full
PI for dosage instructions. Date of first approval: December 2003. Date of revision: 12 November 2019. ORIPRO® is a registered trademark of Orion Laboratories Pty Ltd trading as Perrigo Australia. ABN 56 009 293 136. 25–29 Delawney Street, Balcatta, Western Australia, 6021, AUSTRALIA. https://www.perrigo.com.au. For Medical Information enquiries: 1800 805 546 or AUMedicalInformation@Perrigo.com. To report an adverse event: 1800 805 546, https://www.perrigo.com.au/contact/ or via free fax: 1800 004 110. (2207-ORI-443) Date Prepared July 2022.
PBS Information: Authority required (STREAMLINED) for Assisted Reproductive Technology. Refer to PBS schedule for full authority information. Authority required (STREAMLINED) for Prevention of Preterm Birth in patients with a singleton pregnancy AND at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth.