默克大药厂（也称作默沙东，英文：Merck & Co., Inc.，NYSE：MRK），在美国与加拿大之外的地区称为默克大药厂（Merck Sharp & Dohme，MSD），知名美国制药公司。
美国默克于9月4日宣布，公司旗下Keytruda®（pembrolizumab）正式成为美国食品药品监督管理局（FDA）批准的首例PD-1单抗。该药适应症为不可切除的或转移性黑色素瘤。
Pembrolizumab是一种新型人源化单抗，通过作用于程序性细胞死亡1（PD - 1的）提升人体免疫力，消灭晚期黑色素瘤。
根据临床I期数据显示，24%黑色素瘤患者在接受治疗之后体内的肿瘤大小出现缩小。
默克公司正在进行晚期黑色素瘤的临床II期研究和临床III期研究，为该药物提供进一步研究支持。
公司计划在未来一周内正式上市Pembrolizumab。
Keytruda (pembrolizumab) Powder for Injection
Company: Merck Sharp & Dohme Corp.
Application No.: 125514
Approval Date: 9/04/2014
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
Approval Letter(s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Office Director Memo (PDF)
Cross Discipline Team Leader Review (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)
MEDICATION GUIDE
KEYTRUDA® (key-true-duh)
(pembrolizumab)
for injection
Expand All for Additional Information
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What is the most important information I should know about KEYTRUDA® (pembrolizumab)?
KEYTRUDA is a medicine that may treat your melanoma by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening.
Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse:
Lung problems (pneumonitis). Symptoms of pneumonitis may include:
shortness of breath
chest pain
new or worse cough
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs
and symptoms of colitis may include:
diarrhea or more bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems (hepatitis). Signs and symptoms of hepatitis may include:
yellowing of your skin or the whites of your eyes
dark urine
nausea or vomiting
feeling less hungry than usual
pain on the right side of your stomach area (abdomen)
bleeding or bruising more easily than normal
Hormone gland problems (especially the thyroid, pituitary, and adrenal glands). Signs and symptoms that your hormone glands are not working properly may include:
rapid heart beat
weight loss
increased sweating
weight gain
hair loss
feeling cold
constipation
your voice gets deeper
muscle aches
dizziness or fainting
headaches that will not go away or unusual headache
Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:
change in the amount or color of your urine.
Problems in other organs. Signs of these problems may include:
rash
changes in eyesight
severe or persistent muscle or joint pains
severe muscle weakness
Getting medical treatment right away may help keep these problems from becoming more serious.
Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid medicines and delay or completely stop treatment with KEYTRUDA, if you have severe side effects.
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What is KEYTRUDA® (pembrolizumab)?
KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma.
KEYTRUDA may be used when your melanoma:
has spread or cannot be removed by surgery (advanced melanoma)
and,after you have tried a medicine called ipilimumab and it did not work or is no longer working
and,if your tumor has an abnormal “BRAF” gene, and you also have tried a different medicine
called a BRAF inhibitor, and it did not work or is no longer working.
It is not known if KEYTRUDA is safe and effective in children less than 18 years of age.
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What should I tell my doctor before receiving KEYTRUDA?
Before you receive KEYTRUDA, tell your doctor if you:
have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have had an organ transplant
have lung or breathing problems
have liver problems
have any other medical problems
are pregnant or plan to become pregnant.
KEYTRUDA may harm your unborn baby.
Females who are able to become pregnant should use an effective method of birth control during and for at least 4 months after the last dose of KEYTRUDA. Talk to your doctor about birth control methods that you can use during this time.
Tell your doctor right away if you become pregnant during treatment with KEYTRUDA.
are breastfeeding or plan to breastfeed.
It is not known if KEYTRUDA passes into your breast milk.
Do not breastfeed during treatment with KEYTRUDA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
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How will I receive KEYTRUDA® (pembrolizumab)?
Your doctor will give you KEYTRUDA into your vein through an intravenous (IV) line over 30
minutes.
KEYTRUDA is usually given every 3 weeks.
Your doctor will decide how many treatments you need.
Your doctor will do blood tests to check you for side effects.
If you miss any appointments, call your doctor as soon as possible to reschedule your
appointment.
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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?”
The most common side effects of KEYTRUDA include:
feeling tired
cough
nausea
itching
rash
decreased appetite
constipation
diarrhea
joint pain
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of KEYTRUDA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
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General information about the safe and effective use of KEYTRUDA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about KEYTRUDA, talk with your doctor. You can ask your doctor or nurse for information about KEYTRUDA that is written for healthcare professionals. For more information, go to www.keytruda.com.
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What are the ingredients in KEYTRUDA?
Active ingredient: pembrolizumab
Inactive ingredients: L-histidine, polysorbate-80, sucrose. May contain hydrochloric acid/sodium hydroxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the Medication Guide for KEYTRUDA® (pembrolizumab) and discuss it with your doctor.
The physician Prescribing Information also is available.
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