50 mg / mL concentrate for infusion solution
durvalumab
1. What IMFINZI is and what it is used for
IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults. It is used when your NSCLC:
- has spread to the lung and can not be removed with surgery, and
- has responded to or stabilized after initial chemotherapy and radiation therapy .
IMFINZI is used to treat a type of lung cancer called widespread small cell lung cancer (ES-SCLC) in adults. It is used when your SCLC:
- has spread to the lungs (or to other parts of the body) and
- have not been treated before.
IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein that is designed to recognize a specific target substance in the body. IMFINZI works by helping the immune system fight cancer.
If you have any further questions on the use of IMFINZI or why you have been prescribed this medicine, ask your doctor or pharmacist.
IMFINZI will be given in combination with cytotoxic drugs for SCLC. It is important that you also read the package leaflets for the chemotherapy treatments that you may receive. If you have any further questions on the use of this product, ask your doctor.
2. What you need to know before you are given IMFINZI
You should not be given IMFINZI
- if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). Talk to your doctor if you are unsure.
Warnings and cautions
Talk to your doctor before giving IMFINZI about:
- you have an autoimmune disease (a disease in which the body’s immune system attacks its own cells).
- you have undergone an organ transplant.
- you have lung problems or breathing problems.
- you have liver problems.
If any of the above apply to you (or you are not sure), talk to your doctor before giving IMFINZI.
When you are given IMFINZI you may get some serious side effects.
If you have any of the following, call your doctor immediately or visit a doctor. Your doctor may give you other medicines that prevent more serious complications and reduce your symptoms. Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI if you have:
- inflammation of the lungs : symptoms may include new or worsening cough, shortness of breath or chest pain.
- Inflammation of the liver : symptoms may include nausea or vomiting, decreased appetite, pain in the right side of the stomach, yellow skin or yellow whites of the eyes, drowsiness, dark urine or having easier bleeding or bruising than normal.
- inflammation of the intestines : symptoms may include diarrhea or more bowel movements than usual, or stools that are black, tar-like or sticky with blood or mucus, severe abdominal pain or tenderness.
- inflammation of glands (especially thyroid , adrenal gland , pituitary gland and pancreas ): symptoms may include palpitations, extreme fatigue, weight gain or loss, dizziness or fainting, hair loss, chills, constipation, headache that does not go away or abnormal headache.
- type 1 diabetes : symptoms may include high blood sugar, a greater hunger or thirst than normal and more frequent urination than normal.
- inflammation of the kidneys : symptoms may include decreased urine output.
- inflammation of the skin : symptoms may include rash, itching , blisters on the skin or sores in the mouth or other moist areas.
- Inflammation of the heart muscle : symptoms may include chest pain, shortness of breath or irregular heartbeat.
- inflammation or muscle problems : the symptoms may include pain or weakness in the muscles or that the muscles quickly become tired.
- infusion-related reactions : symptoms may include chills or tremors, itching or rash, redness , shortness of breath or wheezing, dizziness or fever.
- inflammation of the brain ( encephalitis ) or inflammation of the membranes around the spinal cord and brain ( meningitis ): symptoms may include seizures, neck stiffness, headache, fever, chills, vomiting, photosensitive eyes, confusion and drowsiness.
- inflammation of the nerves: symptoms may include pain, weakness and paralysis of the arms and legs ( Guillain-Barré syndrome ).
- low platelet count: symptoms may include bleeding (bleeding in the nose or gums) and / or bruising.
If you have any of the symptoms listed above, call or see a doctor immediately.
Children and young people
IMFINZI should not be used by children and adolescents under 18 years of age.
Other medicines and IMFINZI
Tell your doctor if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and over-the-counter medicines.
Pregnancy and breastfeeding
Pregnancy
- Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
- If you are a woman and could become pregnant, you must use effective contraception while you are being treated with IMFINZI and for at least 3 months after your last dose .
Breast-feeding
- Tell your doctor if you are breast-feeding.
- Ask your doctor if you can breast-feed during or after treatment with IMFINZI.
- It is not known if IMFINZI passes into breast milk.
Driving and using machines
IMFINZI is unlikely to affect your ability to drive or use machines.
However, if you experience side effects that affect your ability to concentrate and react, you should be careful when driving or using machines.
How to give IMFINZI
IMFINZI is given to you in a hospital or at a clinic under the supervision of an experienced doctor.
- The recommended dose of IMFINZI is 10 mg per kg body weight every two weeks or 1,500 mg every three or four weeks.
- Your doctor will give you IMFINZI via an infusion (drip) into a vein for about 1 hour.
- Your doctor will decide how many treatments you need.
If you miss a visit to get IMFINZI
- Contact your doctor immediately to rebook the visit.
- It is very important that you do not miss a dose of this medicine.If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you receive IMFINZI, you may experience some serious side effects (see section 2).
Talk to your doctor immediately if you get any of the following side effects. They have been reported in clinical trials in patients receiving IMFINZI alone, and include the serious side effects listed in section 2:
Very common (may affect more than 1 in 10 people)
- infection you in the upper respiratory tract
- underactive thyroid gland which can cause fatigue or weight gain
- cough
- diarrhea
- abdominal pain
- skin rash or itching
- fever
Common (may affect up to 1 in 10 people)
- severe lung infections ( pneumonia )
- fungal infection in the mouth
- infection in teeth or in soft parts of the mouth
- flu-like illness
- overactive thyroid gland which can cause palpitations or weight loss
- inflammation of the lungs ( pneumonitis )
- hoarseness ( dysphonia )
- abnormal liver tests (elevated aspartate aminotransferase; elevated alanine aminotransferase )
- night sweats
- muscle pain ( myalgia )
- abnormal renal function tests (elevated blood creatinine)
- pain when urinating
- swelling of the legs (peripheral edema )
- reaction to infusion of the drug which may give rise to fever or redness
Uncommon (may affect up to 1 in 100 people)
- inflammation of the thyroid gland
- decreased secretion of hormones from the adrenal glands which can cause fatigue
- scar tissue in the lungs
- inflammation of the liver which may give rise to nausea or decreased appetite
- blistering on the skin
- inflammation of the stomach or intestines ( colitis )
- inflammation in muscle
- inflammation of the kidneys (nephritis) which can reduce the amount of urine
Rare (may affect up to 1 in 1,000 people)
- a condition that leads to high blood sugar levels ( diabetes mellitus type 1)
- during activity in pituitary a ( hypopituitarism including diabetes insipidus ) which can cause fatigue and an increased urine
- inflammation of the heart
- a condition in which the muscles become weak and quickly tired ( myasthenia gravis ).
- inflammation of the membranes around the spinal cord and brain ( meningitis )
- low platelet count caused by an immune reaction (immunological thrombocytopenia )
- inflammation of the bladder. Signs and symptoms can be frequent and / or painful urination, urgent need to urinate, blood in the urine, pain or pressure in the lower abdomen.
The following adverse reactions have been reported in clinical trials in patients receiving IMFINZI in combination with cytotoxic drugs:
Very common (may affect more than 1 in 10 people)
- low white blood cell count
- low number of red blood cells
- low platelet count
- nausea; vomiting; constipation
- hair loss
- decreased appetite
- feel tired or weak
- cough
Common (may affect up to 1 in 10 people)
- diarrhea
- fever
- low white blood cell count with signs of fever
- skin rash or itching
- underactive thyroid gland; overactive thyroid gland; inflammation of the thyroid gland
- severe lung infections ( pneumonia )
- infection in teeth or in soft parts of the mouth
- abnormal liver tests (elevated aspartate aminotransferase; elevated alanine aminotransferase )
- swelling of the legs (peripheral edema )
- abdominal pain
- inflammation of the mouth or lips
- muscle pain ( myalgia )
- inflammation of the lungs ( pneumonitis )
- infection of the upper airways
- low white blood cell count , red blood cell count and platelets (pancytopenia)
- decreased secretion of hormones from the adrenal glands which can cause fatigue
- inflammation of the liver which may give rise to nausea or decreased appetite
- abnormal renal function tests (elevated blood creatinine)
- pain when urinating
- reaction to infusion of the drug which may give rise to fever or redness
Uncommon (may affect up to 1 in 100 people)
- fungal infection in the mouth
- flu-like illness
- diabetes mellitus type 1
- hoarseness ( dysphonia )
- scar tissue in the lungs
- inflammation of the stomach or intestines ( colitis )
- night sweats
Talk to your doctor immediately if you get any of the side effects listed above.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store IMFINZI
IMFINZI is given to you at a hospital or clinic and the healthcare staff is responsible for storing it. The storage instructions are as follows:
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 carton and label on the vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C to 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
Do not use this medicine if it is cloudy, discolored, or contains visible particles.
Do not save any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of following local requirements.
6. Contents of the packaging and other information
Content declaration
The active substance is durvalumab.
One ml concentrate for solution for infusion contains 50 mg durvalumab.
One vial contains either 500 mg durvalumab in 10 ml concentrate or 120 mg durvalumab in 2.4 ml concentrate.
The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, and water for injections.
What the medicine looks like and contents of the pack
IMFINZI concentrate for solution for infusion is sterile, clear to opalescent, colorless to a slightly yellowish solution that does not contain preservatives, and is free from visible particles.
It is supplied in packs containing either 1 glass vial of 2.4 ml concentrate or 1 glass vial of 10 ml concentrate.
Marketing Authorization Holder and Manufacturer
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