Gleventra

Duchenne muscular dystrophy occurs due to mutations in the gene encoding the protein dystrophin (DMD). These changes in the gene disrupt the function of muscle cells and lead to progressive muscle degradation.
Givinostat prevents muscle degradation by blocking the activity of the enzyme histone deacetylase (HDAC) class 1 and 2 in muscle cells.
If there is no improvement or you feel worse, you should consult a doctor.

Gleventra is used in outpatient (able-to-walk) patients aged 6 years and older for the treatment of Duchenne muscular dystrophy (DMD) receiving concomitant treatment with corticosteroids (drugs with anti-inflammatory effects).

If you have taken Gleventra more than you should have
If you have taken Gleventra at a dose higher than recommended, contact your doctor or hospital.
The doctor will determine which treatment you need. It may include monitoring your heart's functioning.
If you forgot to take Gleventra medication
It is important to take the prescribed dose of the drug.
If you forgot to take Gleventra, take the next dose according to your schedule.
Do not take a double dose to compensate for a missed dose.
If you have stopped taking Gleventra
Do not stop taking Gleventra without consulting your doctor.
If you have any questions about the use of the drug, contact your doctor.

Like all medications, Gleventra can cause undesirable reactions, but they do not occur in everyone.
Possible adverse reactions that may occur when taking the drug
Gleventra:
Very often (may occur in more than 1 person out of 10):
• vomiting;
frequent loose stools (diarrhea);
• abdominal pain;
• decrease in the number of platelets in the blood (thrombocytopenia);
• fever;
• Elevated blood triglyceride levels (hypertriglyceridemia).
Often (may occur in no more than 1 person out of 10):
• inflammation of the mucous membrane of the stomach and small intestine (gastroenteritis);
• constipation;
• anxiety;
• dizziness;
• accumulation of blood under the skin (hematoma);
• fatigue (tiredness);
• decreased appetite;
• muscle pain (myalgia);
• joint pain (arthralgia);
• muscle weakness;
• redness of the skin (erythema);
• skin rash;
• thyroid dysfunction (increased levels of thyroid-stimulating hormone in the blood).

Do not take Gleventra:
- if you or your child are allergic to givinostat or any other components of the drug (listed in section 6 of the leaflet).
Special instructions and precautions
Consult your doctor before taking Gleventra.
The information in this leaflet applies to you or your child, if the drug is intended for him.
Laboratory tests
Before starting treatment and throughout the course of treatment with Gleventra, your doctor will
perform blood tests for:
− control of the number of blood cells since when taking Gleventra, it is possible to reduce the number of blood cells, especially platelets responsible for blood clotting, and the development of dose-dependent thrombocytopenia (a decrease in the number of platelets affecting blood clotting) and neutropenia (a decrease in the number of neutrophils), as well as a decrease in hemoglobin levels. Before starting treatment with a givinostat, your doctor will ask you to take a complete blood test. Blood counts should be monitored every 2 weeks during the first 2 months of treatment, at the 3rd month, and then every 3 months thereafter. In case of confirmed thrombocytopenia, the doctor may change the dosage regimen of Gleventra. If deviations from the norm increase, despite a change in the dose of the drug, the doctor may completely stop drug therapy. If you need to increase the dose of the drug due to weight gain, your doctor will carefully monitor your platelet count every 2 weeks for the first 2 months after increasing the dose.
Tell your doctor if you experience unexpected bleeding.
− control of lipid (triglyceride) levels since treatment with Gleventra may be associated with an increase in lipid levels. Your doctor will monitor your triglyceride levels after 3 months, 6 months, and then every 6 months, changing the dose of the drug if necessary. The doctor will stop treatment with Gleventra if the triglyceride level remains elevated despite proper diet and dose adjustment.
Disorders of the digestive system
Undesirable reactions may occur while taking Gleventra, such as frequent loose stools (diarrhea), vomiting, and abdominal pain. Your doctor may prescribe antiemetics, antidiarrheal medications, and medications to prevent significant fluid loss.
If necessary, the doctor will change the dosage regimen of Gleventra or stop therapy if diarrhea and vomiting persist.
Cardiac arrhythmias
Possible cardiac arrhythmias (prolongation of the QTc interval on the electrocardiogram
(ECG)) when taking high doses of givinostat (5 times the recommended dose).
Tell your doctor if you have heart disorders (increased risk of ventricular arrhythmias, congenital long QT syndrome, coronary heart disease, electrolyte disturbances (violations of the water-salt balance in the body)) or you are using drugs that cause prolongation of the QT interval (check with your doctor), since in this case the doctor will prescribe givinostat with caution, with ECG monitoring before starting treatment with givinostat, during simultaneous use with other drugs and according to clinical indications. If you have hypokalemia (a decrease in blood potassium levels), your doctor will correct your condition before starting treatment and will monitor you during therapy in case of dehydration (dehydration) due to diarrhea.
If necessary, the doctor may decide to discontinue treatment with Gleventra.

Tell your doctor what you are using, have recently used, or can start using.
use any other medications.
Your doctor needs to know about the medications you are using in order to take into account possible
undesirable reactions that may develop due to the interaction of various
medications with Gleventra, and it is also possible to change the doses used by you
drugs.
Tell your doctor if you have used or are using any of the following
below the drugs:
• anesthetics (drugs for anesthesia): sevoflurane, propofol;
• antiarrhythmic drugs (drugs for the treatment of cardiac arrhythmias): amiodarone, sotalol;
• antiemetic drugs: ondansetron;
• antibiotics: azithromycin, clarithromycin, ciprofloxacin;
• antifungal drugs: fluconazole;
• drugs for the treatment of mental disorders: aripiprazole, risperidone;
• H2-histamine receptor blockers: famotidine (anti-ulcer drug);
• antithrombotic drugs (drugs for the prevention and treatment of blood clots);
• immunosuppressants to prevent transplant rejection: tacrolimus, sirolimus;
• indinavir (a drug for the treatment of chronic hepatitis B and/or HIV);
• sildenafil (a drug for the treatment of erectile dysfunction);
• eletriptan (a medication for the treatment of migraines);
• drugs for lowering cholesterol in the blood: lovastatin, simvastatin;
• midazolam (sleeping pill);
• metformin (a drug for the treatment of type 2 diabetes).
Tell your doctor if you have used or are using any of the following
medicinal products or if you plan to apply any of them during
treatment with Gleventra.

The holder of the registration certificate
Russian Federation
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone: +7 (495) 640-25-28
Email: reception@promomed.pro
Manufacturer
Russian Federation
JSC "Biochemist"
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia

For any information about the drug, as well as in cases of claims, you should
contact the local representative of the registration certificate holder:
Russian Federation
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Keep the medicine out of the reach of children.
Do not take the drug after the expiration date (shelf life) indicated on the
a bottle after "Before" and a cardboard pack after "Good before".
The expiration date is the last day of the given month.
Unopened bottle
Store in an upright position at a temperature not exceeding 25 °C. Store in the original packaging
packaging (bottle in a pack) for protection from light. Do not freeze.
After the first autopsy
After the first opening, it is allowed to store no more than 60 days in an upright position.
at a temperature not exceeding 25 °C.
Do not dispose (pour) the drug into the sewer. Ask the pharmacy employee how
drugs that are no longer needed should be disposed of (destroyed). These measures are
they will help protect the environment.

If you are pregnant or breastfeeding, assume that you have become pregnant, or plan to
pregnancy, consult your doctor before taking the drug.
There is no information about the use of Gleventra during pregnancy in humans.
The risk to your unborn child cannot be completely eliminated. Therefore, the drug
Gleventra is not recommended during pregnancy and for women who may become pregnant.
and they don't use contraception.4
It is not known whether Gleventra penetrates into breast milk. The risk to children who are
breast-feeding is impossible to exclude. When using the drug Gleventra
It is recommended to stop breastfeeding.

You may experience dizziness and fatigue while taking Gleventra.
If such undesirable reactions occur abstain from management
driving vehicles and operating machinery (until these symptoms disappear).