KEYTRUDA (Page 20 of 21)
14.19 Adult Classical Hodgkin Lymphoma and Adult Primary Mediastinal Large B-Cell Lymphoma: Additional Dosing Regimen of 400 mg Every 6 Weeks
The efficacy and safety of KEYTRUDA using a dosage of 400 mg every 6 weeks for the classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma indications for adults was primarily based on the dose/exposure efficacy and safety relationships and observed pharmacokinetic data in patients with melanoma [see Clinical Pharmacology (12.2)].
16 HOW SUPPLIED/STORAGE AND HANDLING
KEYTRUDA injection (clear to slightly opalescent, colorless to slightly yellow solution):
Carton containing one 100 mg/4 mL (25 mg/mL), single-dose vial (NDC 0006-3026-02)
Carton containing two 100 mg/4 mL (25 mg/mL), single-dose vials (NDC 0006-3026-04)
Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Immune-Mediated Adverse Reactions
- Inform patients of the risk of immune-mediated adverse reactions that may be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid treatment and interruption or discontinuation of KEYTRUDA. These reactions may include:
- Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1)].
- Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain [see Warnings and Precautions (5.1)].
- Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding [see Warnings and Precautions (5.1)].
- Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, or Type 1 diabetes mellitus [see Warnings and Precautions (5.1)].
- Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis [see Warnings and Precautions (5.1)].
- Severe skin reactions: Advise patients to contact their healthcare provider immediately for any signs or symptoms of severe skin reactions, SJS or TEN [see Warnings and Precautions (5.1)].
- Other immune-mediated adverse reactions:
- Advise patients that immune-mediated adverse reactions can occur and may involve any organ system, and to contact their healthcare provider immediately for any new or worsening signs or symptoms [see Warnings and Precautions (5.1)].
- Advise patients of the risk of solid organ transplant rejection and to contact their healthcare provider immediately for signs or symptoms of organ transplant rejection [see Warnings and Precautions (5.1)].
Infusion-Related Reactions
- Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.2)].
Complications of Allogeneic HSCT
- Advise patients of the risk of post-allogeneic hematopoietic stem cell transplantation complications [see Warnings and Precautions (5.3)].
Embryo-Fetal Toxicity
- Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5), Use in Specific Populations (8.1, 8.3)].
- Advise females of reproductive potential to use effective contraception during treatment with KEYTRUDA and for 4 months after the last dose [see Warnings and Precautions (5.5), Use in Specific Populations (8.1, 8.3)].
Lactation
- Advise women not to breastfeed during treatment with KEYTRUDA and for 4 months after the last dose [see Use in Specific Populations (8.2)].
Laboratory Tests
- Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests [see Warnings and Precautions (5.1)].
Manufactured by: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA
U.S. License No. 0002
For patent information: www.msd.com/research/patent
The trademarks depicted herein are owned by their respective companies.
Copyright © 2014-2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.All rights reserved.
uspi-mk3475-iv-2308r066
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: April 2023 | ||
MEDICATION GUIDEKEYTRUDA® (key-true-duh)(pembrolizumab)injection | |||
What is the most important information I should know about KEYTRUDA? | |||
KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. | |||
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: | |||
Lung problems | |||
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Intestinal problems | |||
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Liver problems | |||
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Hormone gland problems | |||
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Kidney problems | |||
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Skin problems | |||
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Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: | |||
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Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: | |||
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Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had. | |||
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your healthcare provider will monitor you for these complications. | |||
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with KEYTRUDA. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects. | |||
What is KEYTRUDA? | |||
KEYTRUDA is a prescription medicine used to treat: | |||
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Before receiving KEYTRUDA, tell your healthcare provider about all of your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | |||
How will I receive KEYTRUDA? | |||
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What are the possible side effects of KEYTRUDA? | |||
KEYTRUDA can cause serious side effects. See “What is the most important information I should know about KEYTRUDA?” | |||
Common side effects of KEYTRUDA when used alone include: feeling tired, pain, including pain in muscles, rash, diarrhea, fever, cough, decreased appetite, itching, shortness of breath, constipation, bones or joints and stomach-area (abdominal) pain, nausea, and low levels of thyroid hormone. | |||
Side effects of KEYTRUDA when used alone that are more common in children than in adults include: fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells. | |||
Common side effects of KEYTRUDA when given with certain chemotherapy medicines include: feeling tired or weak, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, trouble breathing, fever, hair loss, inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs, swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, mouth sores, headache, weight loss, stomach-area (abdominal) pain, joint and muscle pain, and trouble sleeping. | |||
Common side effects of KEYTRUDA when given with chemotherapy and bevacizumab include: tingling or numbness of the arms or legs, hair loss, low red blood cell count, feeling tired or weak, nausea, low white blood cell count, diarrhea, high blood pressure, decreased platelet count, constipation, joint aches, vomiting, urinary tract infection, rash, low levels of thyroid hormone, and decreased appetite. | |||
Common side effects of KEYTRUDA when given with axitinib include: diarrhea, feeling tired or weak, high blood pressure, liver problems, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands and soles of your feet, nausea, mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina, hoarseness, rash, cough, and constipation. | |||
Common side effects of KEYTRUDA when given with lenvatinib include: low levels of thyroid hormone, high blood pressure, feeling tired, diarrhea, joint and muscle pain, nausea, decreased appetite, vomiting, mouth sores, weight loss, stomach-area (abdominal) pain, urinary tract infection, protein in your urine, constipation, headache, bleeding, blisters or rash on the palms of your hands and soles of your feet, hoarseness, rash, liver problems, and kidney problems. | |||
Common side effects of KEYTRUDA when given with enfortumab vedotin include: rash, tingling or numbness of the arms or legs, feeling tired, hair loss, weight loss, diarrhea, itching, decreased appetite, nausea, changes in sense of taste, urinary tract infections, constipation, swelling of your arms, hands, legs and feet, dry eye, dizziness, joint aches, and dry skin. | |||
These are not all the possible side effects of KEYTRUDA. | |||
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
General information about the safe and effective use of KEYTRUDA | |||
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about KEYTRUDA that is written for health professionals. | |||
What are the ingredients in KEYTRUDA? | |||
Active ingredient: pembrolizumab | |||
Inactive ingredients: KEYTRUDA injection: L-histidine, polysorbate 80, sucrose, and Water for Injection. | |||
Manufactured by: Merck Sharp & Dohme LLCRahway, NJ 07065, USA | U.S. License No. 0002For patent information: www.msd.com/research/patentCopyright © 2014-2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.All rights reserved. usmg-mk3475-iv-2304r055For more information, go to www.keytruda.com. |
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