Romisan (Romisan) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Romisan is used to treat cancers of the colon and rectum. It is usually given with other cancer medicines in a combination chemotherapy.
Romisan may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
As a single-agent or combination treatment of patients with: Metastatic carcinoma of the colon or rectum that has recurred or progressed following 5-fluorouracil (5-FU)-based therapy; previously untreated metastatic carcinoma of the colon or rectum; non-small-cell lung cancer (NSCLC); small-cell lung cancer; cervical and ovarian cancer; inoperable or recurrent gastric cancer; esophageal cancer.
Romisan in combination with cetuximab is indicated for the treatment of patients with EGFR-expressing metastatic colorectal cancer after failure of Romisan-including cytotoxic therapy.
Romisan in combination with 5-FU, folinic acid (FA) and bevacizumab is indicated for 1st-line treatment of patients with metastatic carcinoma of the colon or rectum.
As a single-agent treatment of patients with glioma.
How should I use Romisan?
Use Romisan as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Romisan is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Romisan at home, a health care provider will teach you how to use it. Be sure you understand how to use Romisan. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Romisan if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Drink plenty of water and other clear liquids while using Romisan.
If you spill Romisan on your skin, wash it off right away with soap and water.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Romisan, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Romisan.
Uses of Romisan in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
This medication is used to treat cancer of the colon and rectum.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to treat other types of cancer (such as lung, bone cancer).
How to use Romisan intravenous
This medication is given by injection into a vein by a health care professional. The dosage is based on your medical condition, body size, and response to treatment.
If this medication comes into contact with your skin, wash the skin right away and completely with soap and water. If this medication gets into your eyes, mouth, or nose, flush completely with plenty of water. Consult your doctor for more details.
DBL Romisan Injection Concentrate is an antineoplastic agent of the topoisomerase I inhibitor class.
Romisan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata. It is a pale yellow to yellow crystalline powder, with the empirical formula C33H38N4O6·HCl·3H2O and a molecular weight of 677.19.
Its chemical name is (4S)-4,11-diethyl-4-hydroxy-9-[(4-piperidinopiperidino)carbonyloxy]-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)dione hydrochloride trihydrate.
DBL Romisan Injection Concentrate is supplied as a sterile, aqueous solution of pH 3.5. It is intended for dilution with 5% Glucose Injection or 0.9% Sodium Chloride Injection prior to infusion. The 2 mL and 5 mL injections contain 40 mg and 100 mg of Romisan hydrochloride trihydrate, respectively. In addition to Romisan hydrochloride trihydrate, the ingredients are sorbitol and lactic acid. Sodium hydroxide and hydrochloric acid are used for pH adjustment.
Adults:Monotherapy (for previously treated patients): Recommended Dose: 350 mg/m2 administered as an IV infusion over a 30- to 90- min period every 3 weeks.
Combination Therapy (for previously untreated patients): Safety and efficacy of Romisan in combination with 5-fluorouracil (5-FU) and folinic acid (FA) has been assessed in the following schedule: Romisan Plus 5-FU/FA in a 2-Weekly Schedule: Recommended Dose: 180 mg/m2 administered once every 2 weeks as an IV infusion over a 30 to 90- minutes period, followed by infusion with folinic acid and 5-fluorouracil.
Dose Adjustments: Romisan should be administered after appropriate recovery of all adverse events to grade 0 to 1 NCI-CTC grading (National Cancer Institute Common Toxicity Criteria) and when treatment-related diarrhoea is fully resolved.
At the start of a subsequent infusion of therapy, the dose of Romisan and 5-FU when applicable, should be decreased according to the worst grade of adverse events observed in the prior infusion. Treatment should be delayed by 1-2 weeks to allow recovery from treatment-related adverse events.
With the following adverse events, a dose reduction of 15-20% should be applied for Romisan and/or 5-FU when applicable: Haematological toxicity [neutropenia grade 4, febrile neutropenia (neutropenia grade 3-4 and fever grade 2-4), thrombocytopenia and leucopenia (grade 4)] and nonhaematological toxicity (grade 3-4).
Treatment Duration: Treatment with Romisan should be continued until there is objective progression of the disease or unacceptable toxicity.
Special Populations:Patients with Impaired Hepatic Function: In patients with bilirubin up to 1.5 times the upper limit of the normal range (ULN), the recommended dosage of Romisan is 350 mg/m2. In patients with bilirubin ranging from 1.5 to 3 times ULN the recommended dosage is 200 mg/m2. PATIENTS WITH BILIRUBIN BEYOND 3 TIMES THE ULN SHOULD NOT BE TREATED WITH Romisan.
Patients with Impaired Renal Function: Romisan is not recommended for use in patients with impaired renal function as studies in this population have not been conducted.
Elderly: No specific pharmacokinetic studies have been performed in the elderly. However, the dose should be chosen carefully in this population due to their greater frequency of decreased biological functions. This population therefore requires more intensive surveillance.
Administration: Preparation for IV Infusion: As with any other injectable drugs, the Romisan solution must be prepared aseptically.
Aseptically withdraw the required amount of Romisan solution from the vial with a calibrated syringe and inject into a 250-mL infusion bag or bottle containing either 0.9% sodium chloride or a 5% dextrose solution. The infusion should then be thoroughly mixed by manual rotation.
Romisan infusion solution should be infused into a peripheral or central vein.
Romisan should not be delivered as an IV bolus or an IV infusion <30 min or >90 minutes.
CYP3A4 and/or UGT1A1 Inhibitors: Romisan and active metabolite SN-38 are metabolized via the human cytochrome P450-3A4 isoenzyme (CYP3A4) and uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1). Co-administration of Romisan with inhibitors of CYP3A4 and/or UGT1A1 may result in increased systemic exposure to Romisan and the active metabolite SN-38. Physicians should take this into consideration when administering Romisan with these drugs.
Ketoconazole: Romisan clearance is greatly reduced in patients receiving concomitant ketoconazole, leading to increased exposure to SN-38. Ketoconazole should be discontinued at least 1 week prior to starting Romisan therapy and should not be administered during Romisan therapy.
Atazanavir Sulfate: Co-administration of atazanavir sulfate, a CYP3A4 and UGT1A1 inhibitor has the potential to increase systemic exposure to SN-38, the active metabolite of Romisan. Physicians should take this into consideration when co-administering these drugs.
CYP3A4 Inducers: Anticonvulsants: Concomitant administration of CYP3A inducing anticonvulsants (eg, carbamazepine, phenobarbital or phenytoin) leads to reduced exposure to the active metabolite SN-38. Consideration should be given to starting or substituting non-enzyme-inducing anticonvulsants at least 1 week prior to initiation of Romisan therapy in patients requiring anticonvulsant treatment.
St. John's Wort (Hypericum perforatum): Exposure to the active metabolite SN-38 is reduced in patients taking concomitant St. John's wort. St. John's wort should be discontinued at least 1 week prior to the 1st cycle of Romisan and should not be administered during Romisan therapy.
Other Interactions: Neuromuscular-Blocking Agents: Interactions between Romisan HCl and neuromuscular-blocking agents cannot be ruled out. Since Romisan has anticholinesterase activity, drugs with anticholinesterase activity may prolong the neuromuscular-blocking effects of suxamethonium and the neuromuscular blockade of nondepolarising drugs may be antagonized.
Antineoplastic Agents: The adverse effects of Romisan eg, myelosuppression and diarrhea, would be expected to be exacerbated by other antineoplastic agents having a similar adverse effect profile.
Dexamethasone: Lymphocytopenia has been reported in patients receiving Romisan and it is possible that the administration of dexamethasone as antiemetic prophylaxis may have enhanced the likelihood of lymphocytopenia. However, serious opportunistic infections have not been observed and no complications have specifically been attributed to lymphocytopenia.
Hyperglycemia has been observed in patients with a history of diabetes mellitus or evidence of glucose intolerance prior to administration of Romisan. It is probable that dexamethasone, given as antiemetic prophylaxis, contributed to hyperglycemia in some patients.
Laxatives: Laxative use during therapy with Romisan is expected to worsen the incidence or severity of diarrhea.
Diuretics: Dehydration secondary to vomiting and/or diarrhea may be induced by Romisan. The physician may wish to withhold diuretics during dosing with Romisan and during periods of active vomiting or diarrhea.
Bevacizumab: Results from a dedicated drug-drug interaction trial demonstrated no significant effect of bevacizumab on the pharmacokinetics of Romisan and its active metabolite SN-38.
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 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.
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.
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.
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).
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.
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
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Consumer reported time for results
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Consumer reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology