What are the possible side effects of Romisan?
Get emergency medical help if you have signs of an allergic reaction to Romisan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Also call your doctor at once if you have:
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severe or ongoing vomiting or diarrhea;
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nausea or vomiting that keeps you from drinking enough fluids;
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sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
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pain, redness, numbness, and peeling skin on your hands or feet;
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dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
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low blood cell counts - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.
Common Romisan side effects may include:
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diarrhea, constipation;
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nausea, vomiting, stomach pain, loss of appetite;
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weakness;
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fever, pain, or other signs of infection;
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abnormal liver function tests; or
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temporary hair loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Romisan in details
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Common adverse reactions ( ≥ 30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leucopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, and alopecia.
Common adverse reactions ( ≥ 30%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, and alopecia.
Serious opportunistic infections have not been observed, and no complications have specifically been attributed to lymphocytopenia.
First-Line Combination Therapy
A total of 955 patients with metastatic colorectal cancer received the recommended regimens of Romisan in combination with 5-FU/LV, 5-FU/LV alone, or Romisan alone. In the two phase 3 studies, 370 patients received Romisan in combination with 5-FU/LV, 362 patients received 5-FU/LV alone, and 223 patients received Romisan alone.
In Study 1, 49 (7.3%) patients died within 30 days of last study treatment: 21 (9.3%) received Romisan in combination with 5-FU/LV, 15 (6.8%) received 5-FU/LV alone, and 13 (5.8%) received Romisan alone. Deaths potentially related to treatment occurred in 2 (0.9%) patients who received Romisan in combination with 5-FU/LV (2 neutropenic fever/sepsis), 3 (1.4%) patients who received 5-FU/LV alone (1 neutropenic fever/sepsis, 1 CNS bleeding during thrombocytopenia, 1 unknown) and 2 (0.9%) patients who received Romisan alone (2 neutropenic fever). Deaths from any cause within 60 days of first study treatment were reported for 15 (6.7%) patients who received Romisan in combination with 5-FU/LV, 16 (7.3%) patients who received 5-FU/LV alone, and 15 (6.7%) patients who received Romisan alone. Discontinuations due to adverse events were reported for 17 (7.6%) patients who received Romisan in combination with 5FU/LV, 14 (6.4%) patients who received 5-FU/LV alone, and 26 (11.7%) patients who received Romisan alone.
In Study 2, 10 (3.5%) patients died within 30 days of last study treatment: 6 (4.1%) received Romisan in combination with 5-FU/LV and 4 (2.8%) received 5-FU/LV alone. There was one potentially treatment-related death, which occurred in a patient who received Romisan in combination with 5-FU/LV (0.7%, neutropenic sepsis). Deaths from any cause within 60 days of first study treatment were reported for 3 (2.1%) patients who received Romisan in combination with 5-FU/LV and 2 (1.4%) patients who received 5-FU/LV alone. Discontinuations due to adverse events were reported for 9 (6.2%) patients who received Romisan in combination with 5FU/LV and 1 (0.7%) patient who received 5-FU/LV alone.
The most clinically significant adverse events for patients receiving Romisan-based therapy were diarrhea, nausea, vomiting, neutropenia, and alopecia. The most clinically significant adverse events for patients receiving 5-FU/LV therapy were diarrhea, neutropenia, neutropenic fever, and mucositis. In Study 1, grade 4 neutropenia, neutropenic fever (defined as grade 2 fever and grade 4 neutropenia), and mucositis were observed less often with weekly Romisan/5-FU/LV than with monthly administration of 5-FU/LV.
Tables 5 and 6 list the clinically relevant adverse events reported in Studies 1 and 2, respectively.
Table 5: Study 1: Percent (%) of Patients Experiencing Clinically Relevant Adverse Events in Combination Therapies Other includes events such as accidental injury, hepatomegaly, syncope, vertigo, and weight loss
The incidence of akathisia in clinical trials of the weekly dosage schedule was greater (8.5%, 4/47 patients) when prochlorperazine was administered on the same day as Romisan than when these drugs were given on separate days (1.3%, 1/80 patients). The 8.5% incidence of akathisia, however, is within the range reported for use of prochlorperazine when given as a premedication for other chemotherapies.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Romisan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Myocardial ischemic events have been observed following Romisan therapy. Thromboembolic events have been observed in patients receiving Romisan.
Symptomatic pancreatitis, asymptomatic pancreatic enzyme elevation have been reported. Increases in serum levels of transaminases (i.e., AST and ALT) in the absence of progressive liver metastasis have been observed.
Hyponatremia, mostly with diarrhea and vomiting, has been reported.
Transient dysarthria has been reported in patients treated with Romisan; in some cases, the event was attributed to the cholinergic syndrome observed during or shortly after infusion of Romisan.
Interaction between Romisan and neuromuscular blocking agents cannot be ruled out. Romisan has anticholinesterase activity, which may prolong the neuromuscular blocking effects of suxamethonium and the neuromuscular blockade of non-depolarizing drugs may be antagonized.
What is the most important information I should know about Romisan?
- Romisan may cause drowsiness, dizziness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Romisan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
- If swelling occurs at the injection site, apply ice to the area.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Romisan. Avoid close contact with anyone who has recently received a live vaccine. Talk with your doctor before you receive any vaccine.
- If you experience diarrhea more than 24 hours after receiving a dose of Romisan, contact your doctor immediately. Have loperamide available to take at the first sign of a loose stool. Check with your doctor for the appropriate dose.
- Avoid use of laxatives because of the risk of increased diarrhea. Contact your doctor to discuss any laxative use.
- If you are unable to drink fluids while using Romisan, contact your doctor right away.
- Your hair may fall out while using Romisan. It usually grows back after treatment.
- Romisan may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Report any symptoms of fluid or electrolyte loss to your doctor (eg, unusual drowsiness; dizziness; lightheadedness; dry mouth; infrequent urination; lack of energy; low blood pressure; muscle pain or cramps; muscle weakness; rapid heartbeat; stomach disorders, such as nausea and vomiting; thirst; restlessness; weakness).
- Lab tests, including white blood cell counts, hemoglobin, and platelet counts, may be performed while you use Romisan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Romisan with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of early- and late-onset diarrhea.
- Romisan should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Romisan may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Romisan while you are pregnant. It is not known if Romisan is found in breast milk. Do not breast-feed while taking Romisan.
Romisan contraindications
DBL Romisan Injection Concentrate is contraindicated in patients with a known hypersensitivity to Romisan hydrochloride or to any excipients of DBL Romisan. DBL Romisan Injection Concentrate antigenicity has not been observed in clinical trials, but Romisan hydrochloride antigenicity occurred in tests for passive cutaneous anaphylaxis in guinea pigs and rabbits and in tests for active systemic anaphylaxis in guinea pigs. In these tests, both animal species produced antibodies against Romisan hydrochloride and some deaths occurred in guinea pigs sensitised to Romisan hydrochloride.
DBL Romisan Injection Concentrate is contraindicated in women who intend to become pregnant.
DBL Romisan Injection Concentrate is contraindicated in pregnancy and lactation.
Chronic inflammatory bowel disease and/or bowel obstruction; bilirubin 3 times the upper limit of the normal range; severe bone marrow failure; WHO performance status >2; concomitant use with St. John's Wort.
References
- DailyMed. "OMEPRAZOLE MAGNESIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "omeprazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- DTP/NCI. "irinotecan: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Romisan are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Romisan. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
