Lyophilisate for suspension for i / m administration of prolonged action.
Breast cancer: combination therapy with docetaxel of locally advanced or metastatic breast cancer, with chemotherapy failure including an anthracycline drug
monotherapy of locally advanced or metastatic breast cancer, chemotherapy resistant or chemotherapy resistant chemotherapy or chemotherapy if there are contraindications to them.
adjuvant therapy for stage III colon cancer after surgical treatment
therapy for metastatic colorectal cancer.
is the first line therapy for advanced gastric cancer. Indications
genital and extragenital endometriosis
uterine fibroids (before surgery)
female infertility (in the program of in vitro fertilization).
hypersensitivity to triptorelin, other components of the drug and other GnRH analogues.
Caution: the drug should be prescribed for osteoporosis.
Use during pregnancy and lactation
DiferelinÐÂ® is contraindicated in pregnancy and lactation (breastfeeding).
1 vial contains:
Active ingredient: triptorelin acetate, calculated on the basis of triptorelin 3.75 mg *
* – taking into account the peculiarities of the dosage form, the drug contains an excess of the active substance to ensure the introduction of an effective dose.
Excipients: a copolymer of D, L-lactic and glycolic acids – about 160 mg (the amount depends on the level of encapsulation), mannitol – 85 mg, sodium carmellose – 30 mg, polysorbate 80 – 2 mg.
Solvent: mannitol – 16 mg, water d / i – up to 2000 mg.
Dosage and administration
The drug is administered only in / m.
In prostate cancer, DiferelinÂ® is administered at a dose of 3.75 mg (1 injection) every 4 weeks, for a long time.
In case of premature puberty, the drug is prescribed for patients with a body weight of more than 20 kg of 3.75 mg every 28 days, for patients with a body weight of less than 20 kg – 1.875 mg every 28 days.
With endometriosis, the drug is administered at a dose of 3.75 mg once every 4 weeks. The injection is carried out in the first 5 days of the menstrual cycle. The duration of treatment is not more than 6 months.
In female infertility, the drug is prescribed at a dose of 3.75 mg (1 injection) on the 2nd day of the cycle. Communication with gonadotropins should be monitored after desensitization of the pituitary gland (plasma estrogen concentration of less than 50 pkg / ml is usually determined 15 days after injection of DiferelinÂ®).
With uterine fibroids, the drug should be administered in the first 5 days of the menstrual cycle. The drug is prescribed at 3.75 mg every 4 weeks. The duration of treatment is 3 months for patients preparing for surgery.
Rules for the preparation and administration of a suspension
A suspension for i / m administration is prepared by dissolving the lyophilisate in the supplied solvent immediately before administration. Mix the contents of the vial with caution until a homogeneous suspension is obtained.
Cases of incomplete injection resulting in the loss of more suspension than usually remains in the injection syringe should be reported to your healthcare provider.
Introduction should be carried out in strict accordance with the instructions.
Patient should be prone. Disinfect the skin of the buttocks.
Break the neck of the ampoule (dot on the front side of the top).
Put the solvent into the syringe with the needle.
Remove the protective plastic cap from the top of the vial.
Transfer the solvent to the lyophilisate vial.
Pull the needle so that it remains in the vial but does not touch the suspension.
Without turning the bottle over, gently shake the contents until a homogeneous suspension is obtained.
Check the absence of agglomerates before filling the suspension into a syringe (if there are no agglomerates, shake until completely homogeneous).
Without turning the bottle over, draw the entire suspension into the syringe.
Remove the needle used to prepare the suspension and firmly attach the other needle to the tip of the syringe. Hold on to the color tip only.
Remove air from the syringe.
Inject a gluteus muscle immediately.
Dispose of needles in sharps containers.
Allergic reactions: urticaria, rash, itching very rarely – Quincke’s edema.
From the musculoskeletal system: with prolonged use – demineralization of bones, which is a risk of osteoporosis. At the beginning of treatment for prostate cancer, patients may experience a temporary increase in pain in the bones affected by metastases (symptomatic treatment). There are isolated cases of ureteral obstruction and the appearance of symptoms associated with compression of the metastases of the spinal cord (disappear in 1-2 weeks). Also during this period, a temporary increase in the activity of acid phosphatase in blood plasma may be observed.
On the part of the reproductive system: in men – decreased potency in women – headache, depression, sweating and a change in libido, dryness of the vaginal mucosa, dyspareunia and a change in the size of the mammary glands. When used in combination with gonadotropins, cases of the development of ovarian hyperstimulation syndrome have been reported. In the treatment of premature puberty, girls may experience spotting from the vagina. Prolonged use of the drug can cause hypogonadotropic amenorrhea.
From the digestive system: in isolated cases – nausea, vomiting.
From the cardiovascular system: in isolated cases – arterial hypertension, sensation of hot flashes.
From the side of the central nervous system: in isolated cases – increased emotional lability, visual impairment.
Other: in isolated cases – an increase in body weight, an increase in body temperature.
Local reactions: in isolated cases – pain at the injection site.
The drug interaction of DiferelinÂ® has not been described.
There have been no reports of overdoses of DiferelinÂ® to date.
Keep out of the reach of children at a temperature not exceeding 25 ° C.
Ipsen Farma, France