Medicine Overview of Pemro 100mg/4ml Injection
Pemro is used in the treatment of melanoma, non-small cell lung cancer, head and neck cancer, and cervical cancer.
Pemro is given as an infusion into the vein by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.
Some common side effects of this medicine include rash, fatigue, fever, nausea and muscle pain. Some serious side effects which may occur during infusion include chills or shaking, itching, rash, flushing, difficulty breathing and dizziness. Hence, your doctor will check you timely after infusion for allergic reaction.
Before taking it, tell your doctor if you have lung disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Cervical cancer
- Rash
- Fatigue
- Fever
- Musculoskeletal (bone, muscle or joint) pain
- Stomach pain
- Nausea
- Itching
- Constipation
- Indigestion
- Diarrhea
- Decreased appetite
- Cough
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Pemro helps your immune system fight cancer such as that of head, neck, lung, and skin.
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It is usually given through an infusion into your vein (IV) for about 30 minutes, every 3 weeks, by your doctor.
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It may make you feel tired or weak. Do not drive or use machines unless you are sure you are feeling well.
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Take adequate birth control measures while you are being treated with this medicine and for at least 4 months after your last dose, as it can cause harm to an unborn baby.
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Do not stop treatment without talking to your doctor first.
IV Preparation
Reconstitute vial by adding 2.3 mL of Sterile Water for Injection (resulting concentration 25 mg/mL)
Slowly swirl vial; allow up to 5 minutes for bubbles to clear
Do NOT shake vial
Visually inspect reconstituted solution for particulate matter and discoloration prior to administration
Reconstituted solution should appeared clear to slightly opalescent, colorless to slightly yellow solution; discard if extraneous particulate matter other than translucent to white proteinaceous particles is observed
IV infusion preparation
Withdraw required volume from vial(s) and transfer into IV bag containing 0.9% NaCl or D5W; mix diluted solution by gentle inversion
Final concentration of diluted solution: 1-10 mg/mL
Discard any unused portion left in vial
IV Administration
Infuse over 30 minutes through an IV line containing a sterile, nonpyrogenic, low-protein binding 0.2-5 micron in-line or add-on filter
NSCLC (combination therapy): Administer prior to chemotherapy
Do not co administer other drugs through the same infusion line
Intravenous
Metastatic melanoma, Unresectable melanoma
Adult: 2 mg/kg or 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur.
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: In patients who have been treated with chemotherapy: 2 mg/kg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur.
Metastatic non-small cell lung carcinoma
Adult: As first-line treatment: 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur.
Gastro-oesophageal junction adenocarcinoma, Locally advanced urothelial carcinoma, Metastatic gastric cancer, Metastatic microsatellite instability-high cancer, Metastatic squamous cell carcinoma of the head and neck, Metastatic urothelial carcinoma, Recurrent locally advanced gastric cancer, Recurrent squamous cell carcinoma of the head and neck, Refractory classical Hodgkin lymphoma, Relapsed classical Hodgkin lymphoma, Unresectable microsatellite instability-high cancer
Adult: 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur.
Patient with autoimmune disorders. Patients who received allogeneic haematopoietic stem cell transplant (HSCT) or solid organ transplant. Not indicated for multiple myeloma. Pregnancy and lactation.
Lactation
Unknown if distributed in human breast milk
No studies conducted to assess impact of pembrolizumab on milk production or its presence in breast milk
Instruct women to discontinue nursing during treatment and for 4 months after final dose
Significant: Colitis, hepatitis, nephritis, severe endocrinopathies (e.g. diabetic ketoacidosis, diabetes mellitus, hypo- or hyperthyroidism, hypophysitis, severe infusion-related reactions (e.g. hypersensitivity, anaphylaxis); hepatic veno-occlusive disease in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Abdominal pain, constipation, diarrhoea, dry mouth, nausea, vomiting.
General disorders and administration site conditions: Fatigue, asthenia, oedema, chills, pyrexia, influenza-like illness.
Investigations: Increased AST/ALT, alkaline phosphatase, and blood creatinine.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, arthralgia, arthritis, myositis, pain in extremity.
Nervous system disorders: Dizziness, dysgeusia, headache.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea.
Skin and subcutaneous tissue disorders: Dry skin, erythema, pruritus, rash, vitiligo.
Potentially Fatal: Pneumonitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Graft-versus-host-disease and severe sinusoidal obstructive syndrome (in patients with history of HSCT).
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