Rekovelle 12 micrograms/0,36 ml & 36 micrograms/1,08 ml & 72 micrograms/2,16 ml Solution for injection..

Rekovelle 12 micrograms/0,36 ml & 36 micrograms/1,08 ml & 72 micrograms/2,16 ml Solution for injection..

S4
PDF Leaflet Revision Date: 18 May 2021

API: Follitropin Delta | Company: Ferring

Clinical Summary

Quick overview from the medicine insert

Indication

Controlled ovarian stimulation in women undergoing ART.

Dosage (summary)

Individualized based on AMH and body weight; max 24 micrograms.

Onset of Action / Duration

Onset: 5-20 days for follicular development.

Special Populations

  • Renal impairment
  • Hepatic impairment
  • Elderly
  • Paediatric population

Pregnancy & Breastfeeding

Contraindicated in pregnancy and breastfeeding.

Contraindications

  • Hypersensitivity to active substance
  • Tumours of hypothalamus or pituitary gland
  • Ovarian enlargement or cysts not due to PCOS
  • Gynaecological haemorrhages of unknown aetiology
  • Ovarian, uterine or mammary carcinoma
  • Pregnancy and lactation
  • Not for use in males

Common side effects

  • Headache
  • Pelvic discomfort
  • Ovarian hyperstimulation syndrome (OHSS)
  • Pelvic pain
  • Nausea
  • Fatigue

Counselling Points

  • Monitor for OHSS symptoms.
  • Educate on injection technique.
  • Discuss risks of multiple pregnancies.
  • Avoid pregnancy during treatment.

Serious warnings

  • Risk of OHSS
  • Thromboembolic events
  • Ovarian torsion
  • Multiple pregnancy risk
  • Pregnancy loss risk
  • Ectopic pregnancy risk
Important Disclaimer

The Rekovelle 12 micrograms/0,36 ml & 36 micrograms/1,08 ml & 72 micrograms/2,16 ml Solution for injection.. professional information leaflet below is the property of Ferring and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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