Bavencio

Name: Bavencio

Uses of Bavencio

Bavencio is a prescription medication used to treat Merkel cell carcinoma (MCC), a rare, aggressive form of skin cancer, in adults and pediatric patients 12 years and older. Bavencio may be used if the skin cancer has spread (metastatic). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Inform MD

Before taking Bavencio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Bavencio or to any of its ingredients
  • have or have had immune system problems such as Chrohn's disease or ulcerative colitis
  • have had an organ transplant
  • have lung or breathing problems
  • have liver problems
  • have kidney problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Bavencio Usage

Bavencio comes in an injectable form. Your healthcare provider will give you Bavencio into your vein through an intravenous (IV) line over 60 minutes. Bavencio is usually given every 2 weeks.

To help reduce infusion reactions, your doctor may prescribe acetaminophen (Tylenol) and an antihistamine such as diphenhydramine (Benadryl) to be taken prior to the first four infusions and subsequently as needed. 

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Before Using BAVENCIO

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of avelumab injection in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avelumab injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Adrenal problems or
  • Colitis (inflammation of the intestine) or
  • Diabetes or
  • Diabetic ketoacidosis or
  • Hepatitis (inflammation of the liver) or
  • Immune system problems or
  • Nephritis (inflammation of the kidneys) or
  • Pneumonitis (inflammation of the lungs) or
  • Thyroid problems or
  • Type 1 diabetes—Use with caution. May make these conditions worse.

What are some things I need to know or do while I take Bavencio?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may cause very bad side effects. Sometimes these may be life-threatening. These may happen in the lungs, bowels, liver, kidney, pituitary gland, thyroid gland, or other parts of the body. Talk with the doctor.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Infusion reactions have happened with Bavencio. Sometimes, these could be very bad or life-threatening. Talk with the doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Call your doctor right away if you have signs of thyroid, pituitary, or adrenal gland problems. Some signs may be change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine and for at least 1 month after stopping Bavencio.
  • If you get pregnant while taking this medicine or within 1 month after your last dose, call your doctor right away.

How is this medicine (Bavencio) best taken?

Use Bavencio as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.
  • Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of this medicine:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of bowel problems like black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; very bad belly pain; or very bad hard stools (constipation) or loose stools (diarrhea).
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very bad muscle pain or weakness.
  • Very bad joint pain.
  • Any unexplained bruising or bleeding.
  • Change in eyesight.
  • Feeling very tired or weak.
  • Fever or chills.
  • Flushing.
  • Back pain.
  • Very bad belly pain.
  • Swelling in the arms or legs.
  • Dizziness or passing out.
  • Very bad headache.

Bladder cancer treatment:

  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.

How do I store and/or throw out Bavencio?

  • If you need to store Bavencio at home, talk with your doctor, nurse, or pharmacist about how to store it.

Bavencio - Clinical Pharmacology

Mechanism of Action

PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth.

Pharmacokinetics

The pharmacokinetics of avelumab was studied in 1629 patients who received doses ranging from 1 to 20 mg/kg every 2 weeks. The data showed that the exposure of avelumab increased dose-proportionally in the dose range of 10 to 20 mg/kg every 2 weeks. Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing, and the systemic accumulation was approximately 1.25-fold.

Distribution

The geometric mean volume of distribution at steady state for a subject receiving 10 mg/kg was 4.72 L.

Elimination

The primary elimination mechanism of avelumab is proteolytic degradation. Based on population pharmacokinetic analyses in patients with solid tumors, the total systemic clearance was 0.59 L/day and the terminal half-life was 6.1 days in patients receiving 10 mg/kg. In a post hoc analysis, avelumab clearance was found to decrease over time in patients with MCC, with a mean maximal reduction (% coefficient of variation [CV%]) from baseline value of approximately 41.7% (40.0%), which is not considered clinically important. There was no evidence to suggest a change of avelumab clearance over time in patients with UC.

Specific Populations

Body weight was positively correlated with total systemic clearance in population pharmacokinetic analyses. No clinically meaningful differences in pharmacokinetics were observed in the clearance of avelumab based on age; sex; race; PD-L1 status; tumor burden; mild [calculated creatinine clearance (CLcr) 60 to 89 mL/min, n=623 as estimated by the Cockcroft-Gault formula], moderate [CLcr 30 to 59 mL/min, n=320], or severe [CLcr 15 to 29 mL/min, n=4] renal impairment; and mild [bilirubin less than or equal to ULN and AST greater than ULN or bilirubin between 1 and 1.5 times ULN, n=217] or moderate [bilirubin between 1.5 and 3 times ULN, n=4] hepatic impairment. There are limited data from patients with severe hepatic impairment [bilirubin greater than 3 times ULN, n=1], and the effect of severe hepatic impairment on the pharmacokinetics of avelumab is unknown.

Bavencio Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, itchy, feverish, chilled, or have stomach or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

  • sudden chest pain or discomfort, new or worsening cough, feeling short of breath;
  • severe stomach pain, diarrhea, bloody or tarry stools;
  • blistering or peeling skin rash;
  • pounding heartbeats or fluttering in your chest;
  • fever, flu-like symptoms;
  • joint pain, severe muscle pain or weakness;
  • vision changes;
  • liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urination, red or pink urine, swelling in your feet or ankles; or
  • signs of a hormonal disorder--feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, sweating, feeling cold, weight gain, or weight loss.

Common side effects may include:

  • nausea, diarrhea, loss of appetite;
  • feeling tired;
  • bone pain;
  • muscle pain;
  • rash; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bavencio Dosage

Avelumab is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine is usually given once every 2 weeks.

Avelumab must be given slowly and the IV infusion can take at least 60 minutes to complete.

You may be given other medication to prevent certain side effects that may occur during the infusion.

You may need frequent medical tests to help your doctor determine how long to treat you with avelumab.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your avelumab injection.

What is Bavencio?

Bavencio (avelumab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Bavencio is used to treat a type of skin cancer called Merkel cell carcinoma that has spread to other parts of the body. This medicine is for use in adults and children who are at least 12 years old.

Bavencio is also used to treat a certain type of cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. It is given for this condition after other cancer medicines such as cisplatin or carboplatin have been tried without success.

Bavencio was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, further studies are needed.

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