Durvalumab

What is Durvalumab?

• Durvalumab (IMFINZI) is a programmed death-ligand 1 (PD-L1) blocking antibody used to treat certain cancers by working with your immune system.

What are the uses of this medicine?

This 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 small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin 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).

How does this medicine work?

• Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment.
• PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1).
• By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production.
• Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
• Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity (ADCC).

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with IMFINZI .

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosageː Stage III NSCLC:

• Weight 30 kg and more: 10 mg/kg every 2 weeks or 1500 mg every 4 weeks (2.1)
• Weight less than 30 kg: 10 mg/kg every 2 weeks

ES-SCLC:

• Weight 30 kg and more: With etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks in combination with chemotherapy, and then 1500 mg every 4 weeks as a single agent.
• Weight less than 30 kg: With etoposide and either carboplatin or cisplatin, administer IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy, and then 10 mg/kg every 2 weeks as a single agent.

Administration

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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial.
• Injection: 120 mg/2.4 mL (50 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• IMFINZI

What side effects can this medication cause?

The most common side effects of IMFINZI in people with NSCLC include:

• cough
• feeling tired
• inflammation in the lungs
• upper respiratory tract infections
• shortness of breath
• rash

The most common side effects of IMFINZI when used with other anticancer medicines in people with ES-SCLC include:

• nausea
• hair loss
• feeling tired or weak

IMFINZI can cause serious side effects, including:

• Lung problems
• Intestinal problems
• Liver problems
• Hormone gland problems
• Kidney problems
• Skin problems
• Infusion reactions that can sometimes be severe or life-threatening

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
• Withhold or permanently discontinue based on severity and type of reaction.

• IMFINZI can cause severe or life-threatening infusion-related reactions. Interrupt, slow the rate of infusion, or permanently discontinue IMFINZI based on the severity of the reaction.
• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody.
• IMFINZI Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman.
• There are no data on the use of IMFINZI in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of IMFINZI have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: durvalumab
• Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection, USP.

Who manufactures and distributes this medicine?

• Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

By: AstraZeneca UK Limited, 1 Francis Crick Ave. Cambridge, England CB2 0AA

What should I know about storage and disposal of this medication?

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze.
• Do not shake.

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