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According to the results of adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the content of the instructions of the oral preparation of methotrexate.
The relevant matters are hereby announced as follows:
the content of the instructions of the oral preparation of methotrexate.
The relevant matters are hereby announced as follows:
1.
The MAHs of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before February 1, 2023 in accordance with the requirements for the revision of the instructions for methotrexate oral preparations (see annex).
The MAHs of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before February 1, 2023 in accordance with the requirements for the revision of the instructions for methotrexate oral preparations (see annex).
Where the revised content involves drug labels, they shall be revised together, and the instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
3.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
5.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
This is hereby announced
.
.
Annex: Requirements for revision of instructions for oral preparations of methotrexate
NMPA
November 2, 2022
annex
Methotrexate oral formulation label revision requirements
1.
The following should be included under [Black Box Warning].
The following should be included under [Black Box Warning].
2.
The following content should be included under [Adverse Reactions].
The following content should be included under [Adverse Reactions].
Post-IPO experience
After the domestic marketing of methotrexate tablets, the following adverse drug reaction reports were mainly received (in order of the number of reports).
Most of these reports come from spontaneous reports and literature searches, and it is impossible to accurately estimate the number of people taking the drug, and it is difficult to calculate the incidence
.
Most of these reports come from spontaneous reports and literature searches, and it is impossible to accurately estimate the number of people taking the drug, and it is difficult to calculate the incidence
.
Gastrointestinal system: nausea, vomiting, mouth ulcers, abdominal pain, diarrhea, oral mucositis, oropharyngeal pain, bloating, acid reflux, gastrointestinal bleeding, lip ulcers, indigestion, blood in the stool, flatulence, dry mouth, bleeding from the mouth, belching, tongue ulcers, dysphagia, bleeding gums, peptic ulcers, melena, ulcers, tongue pain
.
.
Hepatobiliary system: abnormal liver function, hepatocellular damage, liver injury, hepatitis, jaundice, liver failure
.
.
Skin and subcutaneous tissue: rash, pruritus, alopecia, erythema, skin ulcers, ecchymosis, erythema multiforme, maculopapular rash, vesicular rash, papules, erythematous eruption, urticaria, peeling, dermatitis, pruritic rash, purpura, petechiae, exfoliative dermatitis, skin erosions
.
.
Blood and lymphatic system: myelosuppression, pancytopenia, agranulocytopenia, granulocytopenia, anemia, leukopenia, aplastic anemia, neutropenia, thrombocytopenia, lymphopenia
.
.
Systemic reactions: fatigue, fever, mucosal ulceration, chest tightness, pain, chills, mucosal erosions, chills, facial edema, high fever, peripheral edema, fatigue
.
.
From the nervous system: dizziness, headache, hypoesthesia, tremor
.
.
Immune system: hypersensitivity, anaphylactoid reactions, graft-versus-host disease
.
.
Respiratory system: cough, dyspnea, pneumonia, strep throat, interstitial lung disease, pulmonary fibrosis, respiratory failure
.
.
Infection and infection: pneumonia, cytomegalovirus infection, fungal infection, herpesvirus infection, sepsis, shingles, Epstein-Barr virus infection
.
.
Kidney and urinary system: renal impairment, hematuria, hemorrhagic cystitis
.
.
Cardiovascular system: palpitations, tachycardia, increased
blood pressure.
blood pressure.
Other: loss of appetite, appetite disorders, arthralgia, menstrual irregularities, blurred vision, visual impairment, flushing, tinnitus
.
.
Laboratory abnormalities: low white blood cell count, low platelet count, elevated alanine aminotransferase, low hemoglobin, low neutrophil count, elevated aspartate aminotransferase, elevated γ-glutamyltransferase, decreased red blood cell count, elevated serum uric acid, elevated
alkaline phosphatase.
alkaline phosphatase.
3.
The following content should be included under [Precautions].
The following content should be included under [Precautions].
During the use of this product, blood routine and liver and kidney function should be regularly monitored, and appropriate disposal measures
such as dose reduction and drug withdrawal can be taken if abnormalities are found.
Low-dose folic acid can prevent adverse reactions of this product, but should be used
24 hours after methotrexate.
such as dose reduction and drug withdrawal can be taken if abnormalities are found.
Low-dose folic acid can prevent adverse reactions of this product, but should be used
24 hours after methotrexate.
For patients with hepatic and renal insufficiency, it is recommended to reduce the dose
as appropriate when using.
as appropriate when using.
There have been reports of serious adverse reactions and even death caused by incorrect medication of methotrexate tablets at home and abroad, mainly in elderly patients
with wrong frequency of medication (mostly mistaking "once a week" for "once a day").
。 The most commonly reported adverse reactions in these patients are gastrointestinal system reactions and hematological reactions, including: mouth ulcers, oral mucositis, sore throat, nausea, vomiting, abdominal pain, diarrhea, melena, positive occult blood in the stool, leukopenia, granulocytopenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, etc.
, as well as rash, itching, ecchymosis, fever, fatigue, cough, dyspnea, elevated aminotransferases, abnormal renal function
, etc.
Doctors/pharmacists should fully inform patients and their families of the risk of medication errors in methotrexate tablets, and instruct patients to take the medicine strictly according to the doctor's instructions, and not to change the dosage by themselves
.
If you accidentally overdose this product, you should seek medical attention
as soon as possible.
Folinic acid (leucovorin) and levofolinic acid are antidotes for methotrexate, see [Drug overdose]
for details.
with wrong frequency of medication (mostly mistaking "once a week" for "once a day").
。 The most commonly reported adverse reactions in these patients are gastrointestinal system reactions and hematological reactions, including: mouth ulcers, oral mucositis, sore throat, nausea, vomiting, abdominal pain, diarrhea, melena, positive occult blood in the stool, leukopenia, granulocytopenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, etc.
, as well as rash, itching, ecchymosis, fever, fatigue, cough, dyspnea, elevated aminotransferases, abnormal renal function
, etc.
Doctors/pharmacists should fully inform patients and their families of the risk of medication errors in methotrexate tablets, and instruct patients to take the medicine strictly according to the doctor's instructions, and not to change the dosage by themselves
.
If you accidentally overdose this product, you should seek medical attention
as soon as possible.
Folinic acid (leucovorin) and levofolinic acid are antidotes for methotrexate, see [Drug overdose]
for details.
4.
The following content should be included under [Drug Overdose].
The following content should be included under [Drug Overdose].
Common symptoms of methotrexate overdose are gastrointestinal and hematologic reactions (see [Precautions]).
There are reports of methotrexate tablets at home and abroad that cause overdose, resulting in serious adverse reactions and even death, mainly occurring in elderly patients
with wrong frequency of medication (mostly mistaking "once a week" for "once a day").
There are reports of methotrexate tablets at home and abroad that cause overdose, resulting in serious adverse reactions and even death, mainly occurring in elderly patients
with wrong frequency of medication (mostly mistaking "once a week" for "once a day").
Folinic acid (leucovorin) and levofolinic acid are antidotes
to methotrexate.
An antidote should be given as soon as possible after an overdose of methotrexate, as well as hydration therapy and alkalinization of urine
.
The longer the interval between the administration of methotrexate and the antidote, the less
effective the antidote.
For the specific use of folinic acid (calcium folinate) and levofolinic acid, please refer to the corresponding drug instructions
.
to methotrexate.
An antidote should be given as soon as possible after an overdose of methotrexate, as well as hydration therapy and alkalinization of urine
.
The longer the interval between the administration of methotrexate and the antidote, the less
effective the antidote.
For the specific use of folinic acid (calcium folinate) and levofolinic acid, please refer to the corresponding drug instructions
.
(Note: If the safety content of the original approval specification is more comprehensive or stricter than the content required by this amendment, the original approval content
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
