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DRUGS & SUPPLEMENTS
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Orgalutran Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Orgalutran Injection is contraindicated under the following conditions:
Orgalutran Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Orgalutran, pregnancy must be excluded. Safe use of Orgalutran during pregnancy has not been established.
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during post-marketing surveillance. In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
The packaging of this product contains natural rubber latex which may cause allergic reactions.
Prior to therapy with Orgalutran Injection, patients should be informed of the duration of treatment and monitoring procedures that will be required. The risk of possible adverse reactions should be discussed.
Orgalutran should not be prescribed if the patient is pregnant.
A neutrophil count ≥ 8.3 was noted in 11.9% (up to 16.8 x 109/L) of all subjects treated within the adequate and well-controlled clinical trials. In addition, downward shifts within the Orgalutran Injection group were observed for hematocrit and total bilirubin. The clinical significance of these findings was not determined.
No formal drug-drug interaction studies have been performed.
Long-term toxicity studies in animals have not been performed with Orgalutran Injection to evaluate the carcinogenic potential of the drug. Orgalutran did not induce a mutagenic response in the Ames test or produce chromosomal aberrations in in vitro assay using Chinese Hamster Ovary cells.
Orgalutran Injection is contraindicated in pregnant women. When administered from Day 7 to near term to pregnant rats and rabbits at doses up to 10 and 30 mcg/day (approximately 0.4 to 3.2 times the human dose based on body surface area), Orgalutran increased the incidence of litter resorption. There was no increase in fetal abnormalities. No treatment-related changes in fertility, physical, or behavioral characteristics were observed in the offspring of female rats treated with Orgalutran during pregnancy and lactation.
The effects on fetal resorption are logical consequences of the alteration in hormonal levels brought about by the antigonadotropic properties of this drug and could result in fetal loss in humans. Therefore, this drug should not be used in pregnant women.
Orgalutran Injection should not be used by lactating women. It is not known whether this drug is excreted in human milk.
Clinical studies with Orgalutran Injection did not include a sufficient number of subjects aged 65 and over.
The safety of Orgalutran Injection was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for Orgalutran ranged from 1 to 14 days. Table IV represents adverse events from first day of Orgalutran administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in Ganirelix Acetate-treated subjects without regard to causality.
Adverse Events Occurring in ≥ 1% | Orgalutran N=794 % (n) |
---|---|
Abdominal Pain (gynecological) | 4.8 (38) |
Death Fetal | 3.7 (29) |
Headache | 3.0 (24) |
Ovarian Hyperstimulation Syndrome | 2.4 (19) |
Vaginal Bleeding | 1.8 (14) |
Injection Site Reaction | 1.1 (9) |
Nausea | 1.1 (9) |
Abdominal Pain (gastrointestinal) | 1.0 (8) |
During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose.
Clinical follow-up studies of 283 newborns of women administered Orgalutran Injection were reviewed. There were three neonates with major congenital anomalies and 18 neonates with minor congenital anomalies. The major congenital anomalies were: hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome. The minor congenital anomalies were: nevus, skin tags, sacral sinus, hemangioma, torticollis/asymmetric skull, talipes, supernumerary digit finger, hip subluxation, torticollis/high palate, occiput/abnormal hand crease, hernia umbilicalis, hernia inguinalis, hydrocele, undescended testis, and hydronephrosis.
A subsequent analysis from an observational study in more than 1000 newborns compared the incidence of congenital anomalies in newborns of women administered Ganirelix to historical controls of a GnRH agonist. This analysis included the 283 newborns in the original studies. This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using Ganirelix was comparable with that reported after a COH treatment cycle using a GnRH agonist. The causal relationship between these congenital anomalies and Orgalutran is unknown.
The incidence of congenital malformations after Assisted Reproductive Technology (ART) may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART.
There have been no reports of overdosage with Orgalutran Injection in humans.
After initiating FSH therapy on Day 2 or 3 of the cycle, Orgalutran Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Orgalutran should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS.
Orgalutran Injection is supplied in:
Disposable, sterile, ready for use, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Orgalutran closed with a rubber piston that does not contain latex. Each Orgalutran sterile, prefilled syringe is affixed with a 27 gauge × ½-inch needle closed by a needle shield of natural rubber latex.
Single syringe | NDC 0052-0301-51 |
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Protect from light.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany
For patent information: www.merck.com/product/patent/home.html
Copyright © 1999, 2008 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 03/2016
uspi-mk8761-soi-1603r005
Rx only
Depending on the reaction of the Orgalutran after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Orgalutran not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Orgalutran addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology