What is Keytruda: Side Effects, Dosage, How to use

What is Keytruda: Side Effects, Dosage, How to use

What is Keytruda?

Keytruda is brand name of pembrolizumab. (Brand Names: Keytruda, Generic Name: pembrolizumab)

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Pembrolizumab is an IgG4 kappa immunoglobulin with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells.

KEYTRUDA for injection is a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials. Each vial is reconstituted and diluted for intravenous infusion. Each 2 mL of reconstituted solution contains 50 mg of pembrolizumab and is formulated in L-histidine (3.1 mg), polysorbate 80 (0.4 mg), and sucrose (140 mg). May contain hydrochloric acid/sodium hydroxide to adjust pH to 5.5.

KEYTRUDA injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution. Each 1 mL of solution contains 25 mg of pembrolizumab and is formulated in: L-histidine (1.55 mg), polysorbate 80 (0.2 mg), sucrose (70 mg), and Water for Injection, USP.

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Keytruda uses

Pembrolizumab is used to treat cancer. It works by changing the action of your own immune system, directing it to attack cancer cells. Pembrolizumab belongs to a class of drugs known as monoclonal antibodies.

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

Keytruda is used to treat:

advanced skin cancer (melanoma);

certain types of non-small cell lung cancer;

head and neck cancer;

classical Hodgkin lymphoma in adults and children;

primary mediastinal large B-cell lymphoma;

a certain type of bladder and urinary tract cancer;

a type of cancer that laboratory testing proves to have certain specific DNA mutations, including colorectal cancer;

a certain type of cervical cancer if your tumor tests positive for "PD-L1"; or

advanced stomach cancer if your tumor tests positive for "PD-L1" and has a specific genetic marker (an abnormal "HER2/neu" gene).

Keytruda is often given when the cancer has spread to other parts of the body, or cannot be surgically removed, or has come back after prior treatment.

For some types of cancer, Keytruda is given only if your tumor tests positive for "PD-L1", or if the tumor has a specific genetic marker (an abnormal "EGFR," "ALK," or "HER2/neu" gene).

Furthermore, data: KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unrespectable or metastatic melanoma. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

How to use Keytruda?

Read the Medication Guide provided by your pharmacist before you start receiving pembrolizumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is injected slowly into a vein over 30 minutes. It is given as directed by your doctor, usually once every 3 weeks.

Symptoms of a severe infusion reaction that may occur during pembrolizumab treatment include fever, chills, shaking, flushing, trouble breathing, dizziness, or feeling faint. Tell your healthcare provider right away if you have any of these symptoms during your treatment.

The dosage is based on your medical condition, weight, and response to treatment.

Dosage of Keytruda

Different dosage for each treatment:

Recommended Dosage for Melanoma

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Recommended Dosage for NSCLC

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA should be administered prior to chemotherapy when given on the same day [see Clinical Studies (14.2)]. See also the Prescribing Information for pemetrexed and carboplatin or cisplatin, as appropriate.

Recommended Dosage for HNSCC

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for cHL

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for PMBCL

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Urothelial Carcinoma

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for MSI-H Cancer

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in children is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Gastric Cancer

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Cervical Cancer

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Keytruda

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Side effects of Keytruda

Tiredness, swelling ankles/feet/hands, itchy skin, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: new/worsening cough, shortness of breath, diarrhea with blood/mucus, symptoms of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine, pink/bloody urine), persistent/unusual headache, dizziness/fainting, vision changes, deepening of the voice, eye redness/pain, sensitivity to light, unusual weakness, joint stiffness/pain, muscle weakness/tenderness/pain, signs of infection (such as sore throat that doesn't go away, fever, chills, burning/painful/frequent/urgent urination), easy bruising/bleeding.

Pembrolizumab may cause hormone gland problems (such as thyroid, pituitary, adrenal, pancreas). Your body could make too much or too little hormone. Tell your doctor right away if you have any symptoms such as: cold or heat intolerance, unexplained weight loss/gain, mental/mood changes, slow/fast/pounding/irregular heartbeat, unusual tiredness, constipation.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Get medical help right away if you have any very serious side effects, including: chest pain, seizure.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In summary:

More Common

Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

chills

constipation

cough

depressed mood

difficulty with breathing

difficulty with moving

dry skin and hair

ear congestion

feeling cold

fever

hair loss

headache

hoarseness or husky voice

loss of voice

muscle cramps, pain, and stiffness

pain in the joints

pale skin

rapid weight gain

runny or stuffy nose

slowed heartbeat

sneezing

sore throat

tingling of the hands or feet

trouble breathing

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Less Common

Chest pain

general feeling of discomfort or illness

nervousness

pain

sensitivity to heat

stomach cramps

sweating

tenderness

thickening of bronchial secretions

trouble sleeping

watery or bloody diarrhea

weight loss

Back, leg, or stomach pains

bleeding gums

blurred vision or other change in vision

cracks in the skin

darkened urine

drowsiness

eye pain

fast heartbeat

general body swelling

general tiredness and weakness

indigestion

light-colored stools

loss of appetite

loss of heat from the body

nausea

nosebleeds

pain, swelling, or redness in the joints

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

red, swollen skin

redness of the eye

scaly skin

seizures

sensitivity of the eye to light

tearing

upper right abdominal or stomach pain

vomiting

yellow eyes and skin

Warnings of Keytruda

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

AU TGA pregnancy category: D

US FDA pregnancy category: Not assigned

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 4 months after stopping treatment is not recommended. Consult your doctor before breast-feeding.

This drug may make you dizzy. Alcohol or marijuana can make you dizzier. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Keytruda

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