60 mg powder for infusion solution
paclitaxel
What Apealea is and what it is used for
Apealea is a cancer drug and contains the active substance paclitaxel, which belongs to a group of drugs called taxanes. Paclitaxel affects or inhibits the growth of rapidly dividing cells, such as tumor cells.
Apealea is used to treat the following cancers in adults, in combination with another medicine called carboplatin:
- epithelial ovarian cancer – a cancer of the ovaries (the organ that produces ova in women)
- primary peritoneal cancer – a cancer of the peritoneum (the membrane that sits between the abdominal wall and the internal organs)
- cancer of the fallopian tubes (the connection between the ovaries and the uterus).
It is used when other treatments have not worked.
What you need to know before you get Apealea
Do not take Apealea
- if you are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding
- if the number of neutrophilic leukocytes (a type of white blood cell ) is below 1.5 × 10 9 / l before the start of treatment.
Talk to a doctor or nurse if you are unsure if any of the above apply to you.
Warnings and cautions
Talk to your doctor or nurse before receiving Apealea if you:
- has hepatic, renal, or cardiac impairment – Apealea is not recommended for patients with severe hepatic or renal impairment
- previously had nausea, vomiting, and diarrhea during cancer treatment.
Contact your doctor immediately if you during treatment must
- fever, pain, chills, feeling weak or other signs of infection
- severe nausea, vomiting, or diarrhea
- severe reactions at the infusion site
- an allergic reaction
- numbness, tingling, stinging sensation, sensitivity to touch, or muscle weakness.
You may need additional medication if you get any of these symptoms. Your doctor may want to postpone further treatment with Apealea or reduce the dose.
Ask your doctor or nurse about hair loss and what can be done to avoid it.
You will be closely monitored during treatment
- with regular blood tests to ensure that it is safe for you to continue treatment
- regarding symptoms of an allergic reaction during infusion one, e.g.
- redness and swelling at the infusion site
- low blood pressure
- breathing difficulties
- facial swelling.
Children and young people
Apealea is not recommended for children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Apealea
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, talk to your doctor or nurse before receiving Apealea if you are using the following medicines:
- Ketoconazole or other medicines used to treat fungal infections.
- Erythromycin, rifampicin: drug for the treatment of bacterial infections.
- Fluoxetine: a drug used to treat depression.
- Gemfibrozil: a drug used to lower blood fats.
- Clopidogrel: a drug that reduces the risk of getting blood clots.
- Cimetidine: a drug to reduce stomach acid.
- Efavirenz, nevirapine, ritonavir, saquvinavir, indinavir, nelfinavir: medicines used to treat HIV infection.
- Carbamazepine, phenytoin: drug for the treatment of epilepsy and certain pain conditions.
- Cisplatin: a drug used to treat cancer.
Pregnancy, breastfeeding, and fertility
Tell your doctor before treatment if you are pregnant, think you may be pregnant, or breast-feeding.
Apealea is not recommended during pregnancy, as paclitaxel may cause serious malformations. Patients who may become pregnant should use an effective contraceptive during treatment with Apealea and for six months afterward.
Stop breastfeeding while receiving the treatment, as paclitaxel passes into breast milk and may harm the baby.
Driving and using machines
Apealea can cause side effects such as fatigue or dizziness that may reduce your ability to drive or use machines. Do not drive or use machines if you have these symptoms.
Apealea contains sodium
After reconstitution, this medicinal product contains up to approximately 1.6 g sodium (the main ingredient in table salt/table salt) per dose. This corresponds to 80% of the highest recommended daily intake of sodium for adults.
3. How to get Apealea
You get Apealea from a doctor or nurse by slow drip ( infusion ) into a vein. This will take about an hour. Dose one is based on your body surface area (calculated from your height and weight) and blood test results. The usual dose is 250 mg / m 2 body surface area, which is given every three weeks for up to six treatments.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you get any of the following:
- Very common (may affect more than 1 user in 10 ):
- nerve disorders in the arms and legs, causing tingling, numbness, or burning. *
- Common (may affect up to 1 in 10 people):
- fever
- muscle weakness, cramps, or spasm are
- allergic reactions, such as difficulty breathing, fainting, swelling of the face, itching, feeling hot, chills, especially during your infusion. In rare cases, these can lead to severe allergic shock.
* May persist for more than six months after stopping paclitaxel use.
Other side effects include their frequency:
Very common (may affect more than 1 user in 10 ):
- the low number of neutrophilic leukocytes (a kind of white blood cell )
- loss of appetite
- diarrhea, nausea, vomiting
- hair loss
- pain or discomfort in joints or muscles
- feeling weak, tired
- infusion site reactions such as pain, inflammation, discoloration, redness, swelling, tingling, rash, bleeding.
Common (may affect up to 1 in 10 people):
- the low number of leukocytes and granulocytes (a type of white blood cell )
- low platelet count ( platelets ) or red blood cells
- reduced sensitivity to touch
- abnormal sensory impressions such as tingling, burning, tingling, or numb skin or mouth
- dizziness or a feeling of dizziness
- taste disturbance
- headache
- fast heartbeat
- discomfort or pain in the chest
- low blood pressure, redness ( flushing ), phlebitis, vensmärta, increased blood flow to parts of the body
- difficulty breathing, nasal congestion
- abdominal pain, constipation, flatulence
- dry mouth, inflammation of the oral mucosa
- redness, rash, itching, hives
- pain in e.g. arms, legs, chest or at the tumor a
- back pain, skeletal pain
- swelling of the ankles, feet, face, or fingers.
Uncommon (may affect up to 1 in 100 people):
- blood poisoning
- was in body tissue
- pneumonia, influenza, inflammation of the tonsils
- herpes simplex (a viral infection), respiratory infections
- urinary tract infection, inflammation of the bladder
- skin infections, including infection at the infusion site
- coagulation problems (when the blood clots)
- lack of white and red blood cells and platelets
- low levels of potassium, magnesium, or sodium
- severe fluid loss ( dehydration )
- allergic reactions to other drugs, such as penicillin
- depression, insomnia, anxiety/worry
- an epileptic seizure lasting longer than five minutes or more than one seizure within five minutes
- coma, to feel very sleepy, drowsy, and/or to be severely unaffected
- low muscle tension, facial paralysis
- toxic effects on the nervous system
- cognitive disorder (difficulty thinking or processing thoughts, difficulty remembering)
- brain damage, abnormal fluid accumulation inside the brain
- stroke
- blurred vision, eye problems or irritation, watery eyes
- deafness, inner ear disorder, tinnitus (ringing in the ears)
- vascular disorders, such as
- formation of blood clots
- vascular inflammation
- accumulation of water in the tissue due to blocked lymphatic vessels
- hot flashes
- bleeding
- cardiac arrest, heart failure
- bluish discoloration of lips or skin
- atrial fibrillation (a disorder of the heart rhythm caused by irregular, rapid activity in the atria of the heart)
- to feel their heartbeat ( palpitation er), slow heartbeat
- blood circulation failure
- high blood pressure, changes in blood pressure, pallor
- pulmonary embolism, narrowing of the airways
- severe hypoxia due to abnormal breathing
- difficulty producing voice sounds
- nosebleeds, allergic inflammation inside the nose, runny nose
- cough
- pain or discomfort in the mouth and throat, sore throat, bleeding gums
- inflammation of the abdominal wall, discomfort or swelling in the abdomen, lower abdominal pain
- poor digestion, disturbed bowel function, very hard stools, bloody stools
- inflammation or disorder of the liver, elevated liver enzymes in the blood
- painful severe swelling in deep layers of skin, mainly on the face
- skin discoloration, pigmentation disorder
- dermatitis with blisters
- increased sweating, cold sweats
- dry skin, nail effect
- bleeding in one joint
- the feeling of heaviness in the legs
- multi-organ failure that can lead to death
- tissue swelling caused by excess fluid
- hernia ( hernia )
- feeling of warmth
- low body temperature
- vaginal bleeding
- abnormally high levels of substances that contain nitrogen in the blood.
Has been reported (occurs in an unknown number of users):
- redness and swelling of the palms and soles of the feet which can lead to the skin flaking.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Apealea
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and carton after “EXP”. The expiration date is the last day of the specified month.
O opened vials: Store in a refrigerator (2 ° C – 8 ° C). Keep the vial in the outer carton. Sensitive to light.
After opening, it is recommended that Apealea be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is paclitaxel. Each vial contains 60 mg paclitaxel. After reconstitution, each milliliter solution contains 1 mg paclitaxel (micellar).
- Other ingredients:
- N – ( all-trans pinoresinol) ‑L ‑ cysteic acid methyl ester sodium salt
- N – (13‑ cis ‑retinol) ‑L ‑ cysteic acid methyl ester sodium salt
- sodium hydroxide (for pH adjustment)
See section 2 “Apealea contains sodium”.
What the medicine looks like and the contents of the pack
Apealea is supplied as a greenish-yellow to yellow powder in a glass vial with a rubber stopper and aluminum seal.
Each carton contains 1 glass vial with a powder equivalent to 60 mg paclitaxel.
Marketing Authorization Holder and Manufacturer
Oasmia Pharmaceutical AB
Contact the marketing authorization holder to find out more about this medicine.