Keytruda injection solution 25mg/ml Merck treats cancer (1 vial x 4ml)

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Specifications Pembrolizumab

Ingredient

Thành phần cho 4ml

Composition information	Content
Pembrolizumab	100mg

Uses

indications

Keytruda drugs are indicated in the following cases:

Treatment of malignant skin cancer. Kidney.

Mechanism of impact

Keytruda is a single-line antibody derived from humans, associated with dead cell receptors-1 (PD-1) programming and preventing its interaction with PD-L1 and PD-L2 ligands. PD-1 receptor is a negative regulator that has been shown to be related to the control of immune reactions of T. Keytruda T. Keytruda enhances the reaction of T cells, including anti-tumor reactions, through the blockade of PD-1 links with PD-L1 and PD-L2, which is manifested in antigen-containing cells and can be manifested by tumors in other tumors.

Clinical efficiency and safety

Pembrolizumab dose of 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks and 10 mg/kg every 2 weeks are evaluated in clinical studies of NSCLC or melanoma has been previously treated. Based on modeling and simulating relationships between dosage/exposure to efficiency and safety for PembroLizumab, there is no clinical difference in terms of efficiency or safety between doses of 200 mg every 3 weeks, 2 mg/kg weighing every 3 weeks and 400 mg every 6 weeks.

Dynamic pharmacokinetics

The pharmacokinetics of PembroLizumab have been studied over 2,993 patients with metastatic or unable to remove, NSCLC or carcinoma, who have received a dose of 1 to 10 mg/kg body weight after every 2 to 10 mg/kg body weight every 3 weeks, or 200 mg every 3 weeks.

Absorption

Pembrolizumab is used by intravenously and thus has a biological effect immediately and completely.

Distribution

Suitable for the distribution of external circuit, the distribution of PembroLizumab in a stable state is small (~ 6.0 l; CV: 20%). As expected for an antibody, Pembrolizumab is not linked to plasma proteins in a specific way.

Metabolism

Pembrolizumab is catabolized through nonspecific roads; The metabolism does not contribute to its clearance.

linear/non -linear

The absorption of Pembrolizumab is indicated by the peak concentration (CMAX) or the concentration of the area under the curve (AUC) increases the corresponding dose within the dose range for effective.

Pembrolizumab concentration in a stable state is achieved after 16 weeks of repeating drugs with a 3 -week regimen and body accumulation is 2.1 times. The average bottom concentration (cmin) in a stable state is about 22 mcg/ml at a dose of 2 mg/kg body weight after every 3 weeks and 29 mcg/ml at a dose of 200 mg every 3 weeks. About the median under the time curve of the concentration reaches a stable state in 3 weeks (AUC 0-3 weeks) is 794 mcg/ml at a dose of 2 mg/kg body weight every 3 weeks and 1.053 mcg day/ml at a dose of 200 mg every 3 weeks.

After using PembroLizumab 200 mg every 3 weeks in CHL patients, the average cmin observed in a stable state up to 40% higher than in other types of tumors treated in the same dosage; However, the range of bottom concentration is similar. There is no remarkable difference in the average CMAX between CHL and other types of tumors. Based on the safety data available in CHL and other tumors, these differences are not clinically significant.

Elimination

Pembrolizumab Cl is about 23%lower (on average 195 ml/day [CV%: 40%]) After reaching a maximum change in a stable state compared to the first dose (252 ml/day [CV%: 37%]); The decrease in CL over this time is not considered clinically significant. The average value (CV%) for the final half -life is 22 days (32%) in a stable state.

Before taking Keytruda injection solution 25mg/ml Merck treats cancer (1 vial x 4ml)

How to use

keytruda will be provided at the hospital or clinic under the supervision of a doctor with cancer treatment experience.

Sugar used: transmitted into the vein for about 30 minutes.

Dosage

Adults are 200 mg every 3 weeks or 400 mg every 6 weeks.

Children and teenagers aged 3 and older with classic Hodgkin lymphoma, 2 mg/kg body weight (maximum of 200 mg) every 3 weeks.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

In case of an overdose, the patient must be closely monitored on the signs or symptoms of the harmful reaction and conduct appropriate symptomatic treatment.

What to do when you forget 1 dose? If it is nearly time to take the next dose, skip the forgotten dose and take medicine at the next recommended dose. Do not take double dose to compensate for the forgotten dose.

Side Effects

When using Keytruda, you may experience unwanted effects (ADR).

Very popular, ADR> 1/10

Reduce the number of red blood cells.

Reduce the activity of the thyroid gland.

feel less hungry.

Headache.

Difficulty breathing; cough.

Diarrhea; stomach-ache; nausea; vomiting; Constipation.

itching, skin rash.

muscle and bone pain; joint pain.

Feeling tired; Fatigue or abnormal weakness; swelling; Fever.

Popular, 1

Pulmonary infection.

Reduce the number of platelets (more vulnerable to bruising or bleeding); Reduce the number of white blood cells (neutral leukocytes; lymphocytes).

Reactions related to drug transmission.

Excessive thyroid gland; fire; Thyroiditis.

Reducing sodium, potassium or calcium in the blood.

Difficulty sleep - dizziness; Inflammation of numbness, weakness, tingling or burning pain in the arms and legs; Lack of energy; Change taste.

dry eyes.

Abnormal heart rate.

High blood pressure.

pneumonia.

Inflammation; Dry mouth.

Red rashes sometimes have blisters; The skin is discolored; Dermatitis, dry, itchy skin; hair loss; Skin problems like acne.

Muscle pain, aches or pain; pain in the arm or leg; joint pain with swelling.

chills; The disease is like flu.

Increased blood enzymes in the blood; increased blood calcium; Examination of abnormal kidney function.

Not common, 1

Reduce the number of leukocytes (leukocytes and eosinophilia).

Immune disorders can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis).

Pamplitis is located at the bottom of the brain; reduce secretion.

Hormones produced by adrenal glands.

Type 1 diabetes.

Scratch.

eye inflammation; eye pain, irritation, itching or redness; discomfort with illumination; see points.

Myocarditis, can manifest such as shortness of breath, irregular heart rate, feeling tired or chest pain.

Cardiac inflammation; accumulation of liquids around the heart.

Pancreatitis. stomach inflammation.

The ulcer develops on the inner lining of the stomach or the upper part of the small intestine.

hepatitis.

Skin thickening, sometimes scales, skin proliferation, hair color change; Small skin swelling, tumor or ulcer.

Inflammation surrounding the tendon.

nephritis.

Increase amylase level, a type of enzyme decomposition of starch.

Rare, 1

Inflammatory reaction against platelets or red blood cells; Feeling weak, lightheaded, short of your breathing or if your skin looks pale (signs of low red blood cells, may be due to a type of anemia called simple red blood cell property); A condition called lymphocytic hyperlike cells, where the immune system produces too much cells against infections called tissue cells and lymphocytes can cause different symptoms.

encephalitis, can manifest such as confusion, fever, memory or seizures (encephalitis). A condition in which the muscles become weak and easy to fatigue. Bladder or intestinal problems include more frequent urination, non -autonomous urination, difficulty urination and constipation (myelitis).

Soft red acne under the skin- itching, blistering, peeling or sores, and/or ulcers in the mouth or mucosa of the nasal, throat, or genital area (poisoned epidermal necrosis or Stevens-Johnson syndrome).

The disease that the immune system attacks the moisture glands for the body, such as tears and saliva (Sjogren syndrome). Signs and symptoms may include frequent urination and/or pain, want to urinate, bleeding, pain or pressure in the lower abdomen.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Keytruda drugs are contraindicated in cases of hypersensitivity to any component of the drug.

Be cautious when using

Need to notify medical staff if the patient has been and is:

Inferry (body condition attacks its cells).

Pneumonia or pneumonia (called pneumonia).

Previously used ipilimumab, another drug to treat malignant tumors, and had had a serious side effect due to that drug.

Has an allergic reaction to other single -line antibodies.

or being infected with chronic viruses in the liver, including hepatitis B (HBV) or hepatitis C (HCV).

infected with immunodeficiency viruses (HIV) or obtained immunodeficiency syndrome (AIDS) liver damage.

Kidney damage.

has been implanted with solid organs or bone marrow implants (stem cells) using the root of cell donor (alllogeneic).

Need to stop the drug immediately and notify the doctor if you experience the following conditions:

Pneumonia, may include shortness of breath, chest pain or cough.

Inflammation, may include diarrhea or more bowel movement than usual, black stools, black, sticky or bloody stools or mucus, serious stomach pain or pain, nausea, vomiting.

Hepatitis, may include nausea or vomiting, feel less hungry, the right pain of the stomach, jaundice or whites of the eyes, dark urine or bleeding or bruising more easily than usual.

Nephritis, which may include changes in quantity or color of urine.

Hormone inflammation (especially thyroid, pituitary and adrenal glands), may include fast heart rate, weight loss, sweat increase, weight gain, hair loss, colds, constipation, deeper voice, muscle aches, dizziness or fainting, headache without remission or abnormal headache.

Type 1 diabetes, may include feeling hungry or thirst than usual, need to urinate more often or lose weight.

Eye inflammation, may include vision change.

Muscle inflammation, may include pain or muscle weakness.

Myocarditis, may include shortness of breath, irregular heartbeat, feeling tired or chest pain.

Pancreatitis, may include abdominal pain, nausea and vomiting.

Dermatitis, may include rash, itching, blistering, peeling or ulcers, and/or ulcers in the mouth or in the nasal, throat or genital mucosa.

Immune disorders can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis) - encephalitis, may include confusion, fever, memory or convulsions (encephalitis).

Pain, numbness, tingling, or weakness in the arms or legs; Bladder or intestinal problems include more frequent urination, non -control urination, difficulty urination and constipation (myelitis).

Inflammation and biliary scars, may include pain in the upper right part of the stomach, swelling of the liver or spleen, fatigue, itching, or jaundice or the whites of the eye (biliary tract fiber).

Gastritis (gastritis).

Injecting reaction, may include shortness of breath, itching or rash, dizziness or fever.

The ability to drive and operate machines

Keytruda has a small impact on the ability to drive or use your machines. Feeling dizziness, fatigue or weakness are the possible side effects of keytruda. Do not drive or use machines after using Keytruda unless the patient is sure they are healthy.

Pregnancy

Do not use the keytruda for pregnant women unless the doctor recommends special.

Need to notify the doctor if the patient is pregnant, planning a baby.

Keytruda can be harmful or death for your fetus.

Must use adequate contraception while being treated with keytruda and at least 4 months after your last dose.

Breastfeeding period

Do not breastfeed while using keytruda.

It is unclear whether keytruda will go into breast milk.

Drug interaction

There is no official drug interaction research conducted with Pembrolizumab. Because PembroLizumab is removed from circulation through catabolism, no metabolic drugs are expected.

Use systemic corticosteroids or immunosuppressants before starting to use PembroLizumab to avoid because of the ability to interfere with the pharmacological activity and the efficiency of pembrolizumab. However, systemic corticosteroids can be used or other immunosuppressive drugs after starting to use PembroLizumab to treat harmful reactions related to immunity. Corticosteroids can also be used as anesthesia, when Pembrolizumab is used in combination with chemotherapy, such as vomiting prevention and/or to reduce harmful reactions related to chemotherapy.

Storage

Store at temperatures from 2 - 80C. Avoid light.

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