IMFINZI is a prescription medicine used to treat adults with:

-     A type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC:

•             has not spread outside your chest

•             cannot be removed by surgery, and

•             has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

-     A type of lung cancer called lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin as your first treatment when your SCLC:

•             has spread within your lungs or to other parts of the body, (extensive-stage small cell lung cancer, or ES-SCLC).

IMFINZI is used to treat a type of cancer called biliary tract cancer (BTC), such as cancer of the bile ducts (cholangiocarcinoma) and gallbladder. It is used when your BTC:

• has spread within these regions (or to other parts of the body).

IMFINZI alone or in combination with Tremelimumab is used to treat a type of liver cancer, called unresectable hepatocellular carcinoma (uHCC). It is used when your uHCC:

• cannot be removed by surgery (unresectable) and
• may have spread within your liver or to other parts of the body.

When IMFINZI is given in combination with other medicines, it is important that you also read the package leaflet for the specific anti-cancer medicines you may be receiving.

 If you have any questions about these medicines, ask your doctor.

IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognize a specific target substance in the body. IMFINZI works by helping your immune system fight your cancer.

How IMFINZI works

IMFINZI is a monoclonal antibody, which is a type of protein designed to recognize and attach to a specific target substance in the body. IMFINZI is a medicine that may treat your bladder cancer, NSCLC, SCLC, BTC or uHCC by working with your immune system. IMFINZI can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work.

IMFINZI will only be prescribed to you by a doctor with experience in the use of medicines for cancer.

If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor.

  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 not sure.

Warnings and precautions

Talk to your doctor before you are given IMFINZI if:

•                have immune system problems such as Crohn's disease, ulcerative colitis, or lupus

•                have had an organ transplant

•                have lung or breathing problems

•                have liver problems

•                are being treated for an infection

•                are pregnant or plan to become pregnant. IMFINZI can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI.

•                are breastfeeding or plan to breastfeed. It is not known if IMFINZI passes into your breast milk. Do not breastfeed during treatment and for at least 3 months after the last dose of IMFINZI.

If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.

When you are given IMFINZI, you can have some serious side effects.

If you have any of the following, call or see your doctor straight away. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with IMFINZI, if you have severe side effects.

Lung problems (pneumonitis).

•                cough

•                shortness of breath

•                chest pain

Liver problems (hepatitis).

•                yellowing of your skin or the whites of your eyes

•                severe nausea or vomiting

•                pain on the right side of your stomach area (abdomen)

•                dark urine (tea colored)

•                bleeding or bruising more easily than normal

Intestinal problems (colitis).

•                diarrhea or more bowel movements than usual

•                stools that are black, tarry, sticky, or have blood or mucus

•                severe stomach area (abdomen) pain or tenderness

Hormone gland problems

•                headaches that will not go away or unusual headaches

•                eye sensitivity to light

•                eye problems

•                extreme tiredness

•                weight gain or weight loss

•                dizziness or fainting

•                feeling more hungry or thirsty than usual

•                hair loss

•                changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

•                feeling cold

•                constipation

•                your voice gets deeper

•                urinating more often than usual

•                rapid heartbeat

•                increase sweating

•                fast or deep breathing

•                sweet smell to your breath

•                sweet metallic taste in your mouth

•                different odor to your urine or sweat

Kidney problems

•                decrease in the amount of urine

•                blood in your urine

•                swelling of your ankles

•                loss of appetite Skin problems.

•                rash

•                itching

•                skin blistering or peeling

•                painful sores or ulcers in month or nose, throat, or genital area

•                fever or flu-like symptoms

•                swollen lymph nodes

•                Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. Call or see you doctor right away for any new or worsening signs or symptoms, which may include: Chest pain, irregular heartbeats, shortness of breath or swelling of ankles.

•                Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs

•                Double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight

•                Persistent or severe muscle pain or weakness, muscle cramps

•                Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

•                chills or shaking

•                itching or rash

•                flushing

•                shortness of breath or wheezing

•                feel like passing out

•                fever

•                back or neck pain

If you have any of the symptoms listed above, call or see your doctor straight away.

Children and adolescents

IMFINZI should not be used in children and adolescents below 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 medicines obtained without a prescription.

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 who could become pregnant you must use effective birth control 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 human breast milk.

Driving and using machines

IMFINZI is not likely to affect you being able to drive and use machines.

However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.

IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor.

•    Your healthcare provider will give you IMFINZI into your vein through an intravenous (IV) line over 60 minutes.

•    IMFINZI is usually given every 2, 3 or 4 weeks.

•    Your healthcare provider will decide how many treatments you need.

•    Your healthcare provider will test your blood to check you for certain side effects.

The recommended dose is 10 mg of durvalumab per kilogram of your body weight.

When IMFINZI is given in combination with chemotherapy, you will first be given IMFINZI followed by chemotherapy.

When IMFINZI is given in combination with Tremelimumab for your liver cancer, you will first be given Tremelimumab followed by IMFINZI.

Please refer to the package leaflet of the other anti-cancer medicines in order to understand the use of these other medicines. If you have questions about these medicines, ask your doctor.

If you miss an appointment to get IMFINZI

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Like all medicines, this medicine can cause side effects, although not everybody gets them. When you get IMFINZI, you can have some serious side effects (see section 2).

Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with durvalumab, and includes the serious side effects listed in section 2:

Very common (may affect more than 1 in10 people)

•   infections of the upper respiratory tract

•   underactive thyroid gland that can cause tiredness or weight gain.

•   cough

•   diarrhea

•   stomach pain

•   skin rash or itchiness

•   fever

Common (may affect up to 1 in 10 people)

•   serious lung infections (pneumonia)

•   fungal infection in the mouth

•   tooth and mouth soft tissue infections

•   flu-like illness

•   overactive thyroid gland that can cause fast heart rate or weight loss

•   inflammation of the lungs (pneumonitis)

•   hoarse voice (dysphonia)

•   abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased)

•   night sweats

•   muscle pain (myalgia)

•   abnormal kidney function tests (blood creatinine increased)

•   painful urination

•   swelling of the legs (oedema peripheral)

•   reaction to the infusion of the medicine that can cause fever or flushing.

Uncommon (may affect up to 1 in 100 people)

•   inflammation of the thyroid gland

•   decreased secretion of hormones produced by the adrenal glands that can cause tiredness

•   scarring of lung tissue

•   inflammation of the liver that can cause nausea or feeling less hungry

•   blistering of the skin

•   inflammation of the gut or intestine (colitis)

•   inflammation of the muscle

•   inflammation of the kidneys (nephritis) that can decrease the amount of your urine

Rare (may affect up to 1 in 1000 people)

•   a condition leading to high blood sugar levels (type 1 diabetes mellitus)

•   underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine

•   inflammation of the heart

•   a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis)

•   low number of platelets caused by an immune reaction (immune thrombocytopenia)

Talk to your doctor straight away if you get any of the side effects listed above.

IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage. The storage details 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 vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C). Do not freeze.

Store in the original package in order to protect from light.

Do not use if this medicine is cloudy, discolored or contains visible particles.

Do not store any unused portion of the infusion solution for re-use. Any unused medicine or waste material should be disposed of in accordance with local requirements.