Imfinzi: Uses, Dosage and Side Effects

Overview

What is Imfinzi?

Imfinzi is a prescribed medication for curing specific cancers affecting the immune system. Immunotherapy acts by involving the immune system to target and resist cancer-causing cells.

Imfinzi is precisely indicated in the cure of particular types of locally progressive bladder cancer and for non-small cell lung cancer (NSCLC). The active ingredient used is durvalumab, an immunotherapeutic medicinal product.

Imfinzi (durvalumab) is the only FDA-approved immunotherapy for the treatment of extensive-stage small cell lung cancer (SCLC) in various countries, comprising the United States and the European Union to be more prominent among them, because of the successful results of the CASPIAN Phase III trial.¹Overview| Researched based study from Doi.org

How does Imfinzi work?

• Imfinzi behaves as an immune checkpoint inhibitor drug by acting as a human immunoglobin G1 monoclonal antibody.
• Its primary mechanism of action is to block the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 receptor, which is present on the surface of activated T cells.
• As a programmed death ligand inhibitor (PD-L1 inhibitor), Imfinzi plays a critical role in activating the body’s immune response against cancer cells, ultimately enhancing the immune system’s ability to fight against cancer and completely improving treatment outcomes for patients.⁵Overview| Researched based study from Nlm.nih.gov

Uses

Imfinzi Uses and Indications

Imfinzi is a miracle drug that is used to fight against lung cancer.

It is observed in individuals with:

• Non-small cell lung cancer( NSCLC)
• Small cell lung cancer(SCLC)
• Biliary Tract Cancer(BTC))
• Hepatocellular Carcinoma(HCC)²Uses| Researched based study from Fda.gov

Imfinzi has also received approvals for several other conditions such as:

• It is used in combination with Imjudo (tremelimumab) for hepatocellular carcinoma that is not capable of being surgically removed.
• It is used in formerly treated patients with advanced bladder cancer.

The Food and Drug Administration (FDA) authorizes prescription drugs like Imfinzi for specific conditions based on clinical trials and evidence. However, doctors may sometimes also prescribe Imfinzi for off-label use, to treat another disease.³Uses| Researched based study from Nlm.nih.gov

Is Imfinzi authorized for use in children?

• Imfinzi is not approved for use in children, and its safety and efficacy for treating cancer in children have not been established. The drug’s use in pediatric patients is still under investigation, and more research is needed to determine its potential benefits and risks in treating cancers that affect children.

Dosage

Imfinzi Dosage forms and strengths

The quantity of Imfinzi (durvalumab) prescribed by a doctor relies on various factors, which includes:

• The category of cancer being treated
• The individual’s body weight in kilograms(kg)
• Other existing medical conditions
• And any specific side effects experienced during the treatment.

Imfinzi (durvalumab) is available in liquid form in single-dose vials. The vials of Imfinzi are obtainable in two sizes:

• 2.4 mL vial for containing small quantity of the drug
• 10 mL vial for containing large quantity of the drug

Dose for non-small cell lung cancer

• The appropriate dosages of Imfinzi for non-small cell lung cancer (NSCLC) are typically 10 milligrams per kg of the body weight for every 2 weeks or it is given 1500 mg every 4 weeks.

Dose for Extensive-stage small cell lung cancer (ES-SCLC)

• For extensive small cell lung cancer (ES- SCLC), the recommended dose is 1500 mg of durvalumab every 3 weeks for a total of 4 doses in combination with chemotherapy.
• Afterward, Imfinzi is given 1500 mg every 4 weeks.

Dose to Treat Biliary Tract Cancer (BTC)

• The recommended dose is 1500 mg of Imfinzi along with chemotherapy every 3 weeks.
• Afterward, Imfinzi is given alone with a dose of 1500 mg every 4 weeks.

Dose for bladder cancer

• The recommended dose is 10 mg of Imfinzi per kg of the body weight every 2 weeks or 1500 mg every 4 weeks. It is not given as a combination therapy.⁵Dosage| Researched based study from Astrazeneca.ca

How is Imfinzi administered?

• Imfinzi is administered as an intravenous (IV) infusion once every three weeks which means it is slowly injected into a vein over a specific period of time. This process typically takes about 1 hour to complete.
• Patients usually receive their Imfinzi infusions at their doctor’s office, a hospital, or an infusion center, where medical professionals can monitor the treatment closely and address any potential side effects that may arise during the infusion.

For missed dose

• It is crucial to attend all scheduled appointments to receive Imfinzi as part of cancer treatment. However, if a patient happens to miss an appointment, it is essential to consult the Physician to discuss the situation and determine the next steps.⁵Dosage| Researched based study from Astrazeneca.ca

For Overdosing

• It is unlikely to happen as it is given in a hospital setting in strict monitoring environment.

Storage

Storage of Imfinzi Solution

• There are not any preservatives in Imfinzi.
• Therefore, administer the infusion solution instantly after preparation.
• If storage is necessary, it should not surpass 28 days in a cooler at 2°C to 8°C
• Do not store in a freezer or try not to shake it before use.⁵Storage| Researched based study from Astrazeneca.ca

Side effects

What are the Side Effects of Imfinzi?

It’s very essential to agree that not all individuals will experience these side effects, and the severity of the disease can vary depending on the individual. Imfinzi is mostly well tolerated by many patients.

Common side effects

These side effects are present in more than 10% of individuals. It’s quite usual to have at least one or more of them. Imfinzi has some typical side effects that include:

• Cough with or without mucous
• Pneumonia
• Pneumonitis
• Feeling tired
• Fever
• Vomiting
• Changes to thyroid hormone levels
• Hyperglycemia
• Runny or stuffy nose
• Muscle cramps or stiffness
• Excessive sweating
• Numbness of hands or feet
• Abdominal pain
• Skin rash or itchiness
• Hair loss or thinning of the hairs
• Abnormal liver tests
• Swelling of the legs³Side effects| Researched based study from Nlm.nih.gov

Mild side effects

The number of people experiencing these side effects is between 1 and 10 out of every 100 (between 1 and 10%). It’s quite usual to have one or more of them.

There are some obvious side effects of Imfinzi:

• Thrush
• Flu-like symptoms such as sudden fever, body aches, and fatigue
• Headaches
• Nausea
• Hoarseness or loss of voice (Dysphonia)
• Changes in liver and kidney function such as Increased blood creatine, hyperkalemia etc
• Weight gain or weight loss
• Constipation
• Musculoskeletal or bone pain
• Difficulty or pain during urination
• Inflammation of the bowel
• Allergic reactions or hives
• Anemia ⁴Side effects| Researched based study from Nlm.nih.gov
• Skin blisters
• Changes in mood or behavior
• Forgetfulness
• Confusion or sleepiness
• Feeling thirsty
• Fast and deep breathing
• Metallic taste in the mouth
• Increased frequency of urination
• Bruising or bleeding for longer than usual

Rare side effects

These side effects affect less than one out of every 100 people (less than 1% of patients). Here are a few of the rare side effects of Imfinzi therapy:

• Reduced appetite
• Intestinal problems such as colitis
• Diarrhea
• Dark urine (tea color urine)
• Liver problems such as hepatitis
• Symptoms of kidney failure such as blood in the urine
• Swollen ankles
• Severe muscle weakness
• Changes in eyesight
• Severe joint pains
• Low blood sugar levels
• Injury to the adrenal gland
• Scarring of the lungs
• Irregular heart beat such as in myocarditis
• Low level of calcium
• Inflammation of the brain
• Seizures

Precautions

What precautions to be considered before taking Imfinzi?

It’s important for patients and healthcare professionals to be familiar with the risks that can occur while taking the medicine. Some of the precautions to note about Imfinzi include:

• Regular monitoring by the doctor is essential to check for any unwanted effects, and blood and urine tests may be performed during treatment.
• Serious lung problems, liver problems, kidney problems, and colon inflammation may occur with this medicine, and patients should quickly report any related symptoms to their doctor.
• Myocarditis (inflammation of the heart muscle) is a possible side effect, and symptoms like chest pain, fever, rapid heartbeat, or trouble breathing should be reported as early as possible.
• Adrenal, pituitary, or thyroid gland problems may also occur, and changes in mood, behavior, or physical symptoms should be communicated to the appointed doctor.
• Severe skin reactions and nervous system problems can occur, and immediate medical care must be pursued if symptoms arise.
• Thrombocytopenic purpura, a condition affecting blood clotting, is a potential side effect, and related symptoms should be communicated to the doctor.
• Although infusion reactions are uncommon, but they can have a life-changing impact and require immediate medical attention if they occur.
• Patients who have undergone organ transplantation may have an increased risk of possible transplant rejection while on Imfinzi, and this risk should be discussed with the doctor.⁵Precautions| Researched based study from Astrazeneca.ca
• Avoid immunizations with live vaccines while undergoing treatment with Imfinzi for up to 12 months after the last dose.

During Pregnancy and Breastfeeding

• Imfinzi is not suggested for use during pregnancy.
• Women of childbearing age who are getting the treatment with Imfinzi are advised to take up helpful contraception during the therapy period and for at least 3 months following the last dose.
• Regarding breastfeeding and Imfinzi, the drug’s passage into breast milk is not known.
• It is recommended to avoid breastfeeding during or after treatment with Imfinzi.⁵Precautions| Researched based study from Astrazeneca.ca

Drug Interactions

Drug-Drug Interactions

Imfinzi has the possibility to interact with other drugs, including prescription medications, over-the-counter medicines, vitamins, and herbal products.

Drug Interactions between Dexamethasone and Imfinzi

• Corticosteroids may affect the pharmacodynamic effects and efficacy of the drug.⁵Interactions| Researched based study from Astrazeneca.ca

Interactions between Imfinzi and prednisone

• Oral or intravenous corticosteroid is associated with decreased response and overall poorer outcomes.⁵Interactions| Researched based study from Astrazeneca.ca
• It is recommended to discontinue corticosteroid treatment before starting Imfinzi therapy.

Interactions between Imfinzi and thalidomide Analogues

• It has the potential to interact and cause significant harm. The risk of blood clots in arteries, veins, and lungs (thromboembolic events) and the risk of heart attack and stroke can be elevated.⁵Interactions| Researched based study from Astrazeneca.ca

Takeaway

Key Takeaway

• Imfinzi is a medicine used in the treatment of certain cancers by working with your immune system. It falls under the category of immunotherapy and is part of the group of drugs known as immune checkpoint inhibitors.
• Imfinzi (generic name: durvalumab)is prescribed for the treatment of locally advanced or metastatic bladder cancer, non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC) in specific.
• Imfinzi works by blocking a protein called PD-L1 (programmed death-ligand 1), which helps cancer cells avoid immune system attack. Imfinzi by preventing this interaction, signals the immune system to identify and kill cancer cells.
• Imfinzi may be used alone or alongside other drugs, such as tremelimumab.
• Imfinzi is typically administered through an intravenous infusion, and the treatment schedule varies depending on the specific cancer and its stage.
• During and after treatment with Imfinzi, it is essential to refrain from live vaccinations.
• Breastfeeding is not advisable during the therapy and should be avoided for few months after the final dose.
• Common side effects of Imfinzi may include fatigue, nausea, rash, and muscle pain.
• Alongside with other treatments options like chemotherapy, it has shown improved overall survival rates in certain patients.

Always consult with your doctor or pharmacist to understand the appropriate treatment plan, potential side effects, and any necessary precautions.