Durvalumab
(Redirected from Imfinzi)
What is Durvalumab?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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 ?[edit | edit source]
- This medicine have no usage limitations.
What drug interactions can this medicine cause?[edit | edit source]
- No clinically important drug interactions have been observed with Imfinzi .
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2017.
How should this medicine be used?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- The safety and effectiveness of Imfinzi have not been established in pediatric patients.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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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