about the product

The drug Fulvestrant-Promomed is a solution for intramuscular injection. Externally, it is a transparent, colorless, light yellow or yellow to brownish-yellow viscous liquid.

Specifications

Name
Fulvestrant-Promomed
Dosage form
SOLUTION FOR INTRAMUSCULAR INJECTION
Nosological classification
Antitumor hormonal drugs
INN
FULVESTRANT
Dosages
250 mg/5 ml
ATC code
L02BA03
Active substance
fulvestrant
Pharmacotherapeutic group
Cancer drugs

use

Always use the drug in full accordance with the recommendations of the attending physician. If in doubt, consult your doctor.
Treatment with Fulvestrant-Promomed should be carried out only under the supervision of a doctor with experience in the use of antitumor drugs.
Recommended dose
The recommended dose is 500 mg of fulvestrant (2 injections of 250 mg / 5 ml) once a month.
The first month of therapy: 500 mg 2 times a month (the second administration is 2 weeks after
the first dose of the drug).
Special patient groups
Patients with impaired renal function
In cases of mild or moderate renal impairment (creatinine clearance> 30 ml/min), no dose adjustment is required.
Patients with impaired liver function
The use of Fulvestrant-Promomed in patients with mild or moderate hepatic impairment does not require dose adjustment. However, the use of Fulvestrant-Promomed in this group of patients requires caution. The safety and efficacy of the drug in patients with severe hepatic impairment have not been established.
Route and/or method of administration
Your doctor or nurse will administer Fulvestrant Promomed to you by slow intramuscular injection, one injection into each buttock.
If you have any questions about the use of the drug, contact your doctor.

Help

Package leaflet

The drug Fulvestrant-Promomed is an antitumor hormonal drug. It contains the active ingredient fulvestrant, which belongs to the group of estrogen blockers. Estrogens are female sex hormones, which in some cases are involved in the development of breast cancer.

Fulvestrant-Promomed is used in adult postmenopausal women to treat locally advanced or metastatic (spread to other parts of the body) breast cancer with positive estrogen receptors.:
− previously not receiving endocrine (hormonal) therapy;
− with relapse during or after adjuvant endocrine therapy (additional therapy that is performed to increase the effectiveness of primary therapy) or with progression during endocrine therapy.
If there is no improvement or you feel worse, you should consult a doctor.

There are reports of an overdose of fulvestrant in humans. In animal studies, when high doses of fulvestrant were administered, only effects associated with antiestrogenic activity were observed, such as vaginal dryness, thromboembolism, thrombosis (complete or partial blockage of the vessel lumen by a thrombus), decreased libido (sexual instinct).

Like all medications, Fulvestrant Promomed can cause undesirable reactions, but they do not occur in everyone. It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of the drug, and prescribe additional therapy).
Contact your doctor immediately if you experience the following adverse reactions, as you may need further examination or treatment.:
• allergic reactions, including swelling of the face, lips, tongue, and/or pharynx, and urticaria (redness and itching of the skin). The frequency of this reaction is more than 1 person out of 10;
• Vomiting and diarrhea (diarrhea), as they can lead to dehydration. The frequency of this reaction is no more than 1 person out of 10;
• thromboembolism (sudden blockage of a vessel by a detached fragment or a whole thrombus). It may manifest symptoms such as shortness of breath, rapid heartbeat, decreased blood pressure, the appearance of cold and sticky sweat, loss of consciousness, pallor of the skin, and a slight increase in temperature. The frequency of this reaction is no more than 1 person out of 10;
hepatitis (inflammation of the liver, manifested by decreased appetite, nausea, vomiting, joint pain, fever, yellowing of the skin and whites of the eyes). The frequency of this reaction is no more than 1 person out of 100;
• liver failure, the signs of which may be heaviness in the right hypochondrium, jaundice of the skin and whites of the eyes, weakness, swelling, increased bleeding. The frequency of this reaction is no more than 1 person out of 100.
(For more information about all possible adverse reactions, see the leaflet)

Do not use the drug Fulvestrant-Promomed:

  • if you are allergic to fulvestrant or any other components of the drug (listed in section 6 of the leaflet);
  • if you have severe liver dysfunction;
  • if you are pregnant or breastfeeding.

Tell your doctor that you are taking, have recently taken, or may start taking any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with Fulvestrant-Promomed, and possibly adjust the doses of the medications you are taking.
In particular, you should inform your doctor if you are taking anticoagulants.
Check with your doctor about the interactions of the drug with other medicines.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Do not give the drug to children aged 0 to 18 years, as the safety and efficacy of Fulvestrant-Promomed in this group of patients have not been established.

Keep the drug out of the reach of the child so that the child cannot see it. Do not use the drug after the expiration date (shelf life) indicated on the carton after "Good before". The expiration date is the last day of the given month. Store in the refrigerator (2-8 ° C) in the original packaging (pack). Do not freeze