Gemsol

Leaflet attached to the packaging: patient information

Gemsol, 40 mg/ml, concentrate for solution for infusion

Gemcitabine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Gemsol and what is it used for
• 2. Important information before using Gemsol
• 3. How to use Gemsol
• 4. Possible side effects
• 5. How to store Gemsol
• 6. Contents of the pack and other information

1. What is Gemsol and what is it used for

Gemsol belongs to a group of so-called cytotoxic medicines. These medicines destroy dividing cells, including cancer cells.
Gemsol can be used alone (monotherapy) or in combination with other anticancer medicines, depending on the type of cancer being treated.
Gemsol is used to treat the following cancers:

• non-small cell lung cancer (as monotherapy or in combination with cisplatin),
• pancreatic cancer,
• breast cancer (in combination with paclitaxel),
• ovarian cancer (in combination with carboplatin),
• bladder cancer (in combination with cisplatin).

2. Important information before using Gemsol

When not to use Gemsol

• if the patient is allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is breastfeeding.

Warnings and precautions

Before the first infusion, a blood sample will be taken from the patient to check if their kidney and liver function is sufficient to administer Gemsol. Before each infusion, a blood sample will be taken from the patient to check if it contains enough cells to administer the medicine. Depending on the patient's overall condition and if the number of blood cells is too low, the doctor may change the dose or postpone the administration of the medicine. Periodically, blood samples will be taken from the patient to monitor kidney and liver function.
Before using Gemsol, the patient should discuss with their doctor, nurse, or hospital pharmacist if:

• the patient has ever experienced severe skin rash or skin peeling after using gemcitabine;

or if the patient currently has or has had liver, heart, or blood vessel disease, lung or kidney problems, as the use of Gemsol may not be recommended;

• the patient has recently undergone or is scheduled to undergo radiation therapy, as the use of Gemsol may cause acute or late radiation reaction;
• the patient has recently been vaccinated (especially against yellow fever), as the use of Gemsol may cause complications;
• the patient experiences breathing difficulties or feels very weak and pale, as this may be a sign of kidney failure or lung problems;
• the patient experiences generalized edema, shortness of breath, or weight gain, which may be signs of fluid leakage from small blood vessels into tissues.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP), have been reported with gemcitabine. If the patient experiences any symptoms related to these severe skin reactions, they should contact their doctor immediately.
If the patient experiences symptoms such as headache with confusion, seizures, or vision disturbances, they should contact their doctor immediately, as this may be a very rare side effect affecting the nervous system, known as reversible posterior leukoencephalopathy syndrome.

Children and adolescents

The use of this medicine is not recommended in children under 18 years of age due to insufficient data on safety and efficacy.

Gemsol and other medicines

The patient should inform their doctor or hospital pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including vaccines and over-the-counter medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
Pregnancy
If the patient is pregnant or plans to become pregnant, they should inform their doctor. The use of Gemsol should be avoided during pregnancy. The doctor will inform the patient about the risks associated with the use of Gemsol during pregnancy. Women of childbearing potential must use effective contraception during treatment with Gemsol and for 6 months after the last dose.
Breastfeeding
If the patient is breastfeeding, they should inform their doctor.
Breastfeeding should be discontinued during treatment with Gemsol.
Fertility
Male patients should be informed not to attempt to conceive a child during treatment with Gemsol and for 3 months after its completion, and to use effective contraception during treatment with Gemsol and for 3 months after its completion. If the patient plans to have children during or within 3 months of completing treatment, they should consult their doctor or pharmacist. They can also seek advice on the possibility of freezing sperm before starting treatment.

Driving and using machines

Gemsol may cause drowsiness, especially when combined with alcohol. The patient should not drive or operate machinery until they are sure that Gemsol does not cause drowsiness.

3. How to use Gemsol

The usual dose of Gemsol is 1000 to 1250 mg per square meter of body surface area. The body surface area is calculated based on the patient's height and weight.
The doctor will calculate the appropriate dose based on the body surface area. This dose may be adjusted or its administration may be delayed depending on the number of blood cells and the patient's overall condition.
The frequency of Gemsol infusions depends on the type of cancer being treated.
Gemsol is always administered after dilution as an infusion into a vein. The infusion of Gemsol takes about 30 minutes.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gemsol can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should contact their doctor immediately:

bleeding from the gums, nose, or mouth, or other bleeding that does not stop; red or pink urine; unexplained bruising (as the patient may have a low platelet count, which occurs very often);
fatigue, fainting, rapid breathing, or pale skin (as the patient may have a low hemoglobin level in the blood, which occurs very often);
mild to moderate skin rash (very common) / itching (common) or fever (very common) - allergic reactions;
fever of 38 °C or higher, sweating, or other signs of infection (as the patient may have a low white blood cell count with fever, known as febrile neutropenia, which occurs commonly);
pain, redness, swelling, or ulcers in the mouth (stomatitis, which occurs commonly);
irregular heartbeat (arrhythmia, which occurs rarely);
severe fatigue and weakness, petechiae or small hemorrhages under the skin (purpura), acute kidney failure (low urine output or anuria), and signs of infection - these may be symptoms of hemolytic uremic syndrome, which can be life-threatening;
breathing difficulties (mild dyspnea, which occurs very commonly shortly after the end of the Gemsol infusion and resolves quickly; however, severe respiratory disorders occur uncommonly or rarely);
severe chest pain (myocardial infarction, which occurs rarely);
severe hypersensitivity / allergic reaction with severe skin rash, including redness and itching of the skin, swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat, or feeling of fainting (anaphylactic reaction, which occurs very rarely);
generalized edema, shortness of breath, or weight gain, which may indicate fluid leakage from small blood vessels into tissues (capillary leak syndrome, which occurs very rarely);
headache with vision disturbances, confusion, seizures (reversible posterior leukoencephalopathy syndrome, which occurs very rarely);
severe skin rash with itching, blistering, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis - reactions that occur very rarely);
red, peeling, widespread rash with blisters under swollen skin (including skin folds, trunk, and upper limbs) and blisters with fever - acute generalized exanthematous pustulosis (AGEP - frequency not known);
extreme fatigue and weakness, petechiae or small hemorrhages under the skin (purpura), acute kidney failure (low urine output or anuria), and signs of infection. These may be symptoms of thrombotic microangiopathy (formation of blood clots in small blood vessels) and hemolytic uremic syndrome, which can lead to death.

Other side effects of Gemsol may include:

Very common side effects(may occur in more than 1 in 10 people)

• low white blood cell count
• vomiting
• nausea
• hair loss
• liver function disorders: detected in blood tests
• blood in the urine
• abnormal urine test results: proteinuria
• flu-like symptoms with fever
• swelling of the ankles, fingers, feet, face

Common side effects(may occur in less than 1 in 10 people)

• loss of appetite (anorexia)
• headache
• sleep disturbances
• drowsiness
• cough
• runny nose
• constipation
• diarrhea
• itching
• excessive sweating
• muscle pain
• back pain
• fever
• weakness
• chills
• increased liver function test results (increased bilirubin levels)
• infections

Uncommon side effects(may occur in less than 1 in 100 people)

• pulmonary fibrosis (scarring of the lungs)
• wheezing (bronchospasm)
• pulmonary infiltrates (abnormal chest X-ray)
• stroke
• heart failure
• kidney failure
• severe liver damage, including liver failure and death

Rare side effects(may occur in less than 1 in 1000 people)

• low blood pressure
• skin peeling, ulcers, or blisters
• skin peeling and massive blistering
• reactions at the injection site
• severe pneumonia causing respiratory failure (acute respiratory distress syndrome)
• skin rash similar to severe sunburn, which may occur in previously irradiated areas (radiation recall)
• fluid in the lungs
• pulmonary fibrosis due to radiation therapy (radiation toxicity)
• gangrene of the fingers or toes
• vasculitis
• increased liver function test results (increased GGT - gamma-glutamyltransferase activity)

Very rare side effects(may occur in less than 1 in 10,000 people):

• increased platelet count
• ischemic colitis (inflammation of the colon due to reduced blood flow)
• thrombotic microangiopathy: formation of blood clots in small blood vessels

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• sepsis: a condition in which bacteria and their toxins circulate in the blood and start damaging organs
• pseudoscleroderma: redness and swelling of the skin
• Blood tests show low hemoglobin levels (anemia), low white blood cell count, and changes in platelet count

It is possible for any of the listed symptoms or conditions to occur. If the patient experiences any of the listed side effects, they should inform their doctor immediately.
The patient should consult their doctor if they experience any worrying symptoms.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gemsol

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and on the label after EXP. The expiry date refers to the last day of the month.
Hospital pharmacies should store Gemsol vials at a temperature of 2°C-8°C. Do not freeze.
If the vials are stored at a temperature below 2°C, a precipitate may form in the solution.
If the solution appears discolored or contains visible particles, it should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Gemsol contains

The active substance of the medicine is gemcitabine (as hydrochloride).
Each ml of the concentrate for solution for infusion contains 40 mg of gemcitabine as gemcitabine hydrochloride.
Each 5 ml vial contains 200 mg of gemcitabine (as hydrochloride).
Each 25 ml vial contains 1000 mg of gemcitabine (as hydrochloride).
Each 50 ml vial contains 2000 mg of gemcitabine (as hydrochloride).
The medicine also contains: water for injections and diluted hydrochloric acid (for pH adjustment).

What Gemsol looks like and contents of the pack

The medicine is a concentrate for solution for infusion.
The concentrate is a clear, colorless to pale yellow solution in vials made of colorless glass type I with a stopper (type I) made of halobutyl rubber coated with fluoropolymer, with an aluminum seal, placed in a protective packaging (Onco-Safe or Sleeving) or without such packaging, in a cardboard box. The Onco-Safe and Sleeving packaging do not come into contact with the medicinal product and provide additional protection during transport, thereby increasing the safety of medical and pharmaceutical personnel.
Pack sizes:
Vials of 200 mg: 1, 5, or 10 vials.
Vials of 1000 mg: 1 vial
Vials of 2000 mg: 1 vial

Marketing authorization holder and manufacturer:

EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestrasse 11
4866 Unterach
Austria

Manufacturer:

Fareva Unterach GmbH
Mondseestraße 11
4866 Unterach
Austria

For more information about the medicine and its names in other European Economic Area countries, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of last revision of the leaflet:07/2024
Logo Ebewe
Information intended for healthcare professionals only
It is not recommended to mix Gemsol with other medicinal products due to the lack of compatibility studies.
Medicines administered parenterally should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
The required amount of solution should be transferred under aseptic conditions to an infusion bag or bottle. The solution should be diluted with 0.9% sodium chloride solution or 5% glucose solution.
The solutions should be mixed thoroughly by shaking the bottle or bag.
Handling of the medicine
During the preparation and disposal of the infusion solution, the safety rules for cytotoxic medicines should be followed. The preparation of the solution should be carried out in an isolator or a safe box for working with cytostatics. According to the requirements, protective clothing (protective gown, gloves, mask, safety glasses) should be worn.
The solution may cause severe irritation if it comes into contact with the eyes. In case of eye contamination, the eye should be rinsed immediately with water. If irritation persists, the patient should seek medical attention immediately. In case of skin contact, the affected area should be rinsed thoroughly with water.
Any unused product and materials used for the preparation, dilution, and administration of the solution should be disposed of in accordance with hospital regulations for cytotoxic medicines and local regulations for the disposal of hazardous waste.
Shelf life
Unopened vial:
2 years
Stability after first opening of the packaging:
The chemical and physical stability of the product has been demonstrated for 28 days at a temperature of 2°C to 8°C and at room temperature (15°C - 25°C).
From a microbiological point of view, the product should be used immediately after preparation of the solution.
If the product is not used immediately, the responsibility for the storage time and conditions before use lies with the user. Generally, the storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless the opening of the vial took place under controlled and validated aseptic conditions.
Shelf life after dilution
The chemical and physical stability of the diluted solution (5% glucose solution or 0.9% sodium chloride solution) (1.0 mg/ml, 7.0 mg/ml, and 25 mg/ml) has been demonstrated for 28 days at a temperature of 2°C to 8°C and at room temperature.
From a microbiological point of view, the product should be used immediately after preparation of the solution.
If the product is not used immediately, the responsibility for the storage time and conditions before use lies with the user. Generally, the storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution of the solution took place under controlled and validated aseptic conditions.