Ribozar injection is used together with other medicines (eg, carboplatin) to treat patients with advanced ovarian cancer that has come back at least 6 months after treatment with other cancer medicines (platinum-based).
Ribozar injection is also used together with other medicines (eg, paclitaxel) to treat metastatic (cancer that has spread) breast cancer in patients who have received other treatments that did not work well.
It is also used together with other medicines (eg, cisplatin) to treat non-small cell lung cancer that has advanced, spread, or cannot be treated with surgery.
Ribozar injection is also used to treat pancreas cancer that has advanced or spread to the other parts of the body in patients who have been previously treated with fluorouracil.
Ribozar interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with Ribozar has been stopped.
This medicine is to be given only by or under the direct supervision of your doctor.
Ribozar indications
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.
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Ovarian Cancer
Ribozar for Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Breast Cancer
Ribozar for Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
Non-Small Cell Lung Cancer
Ribozar for Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.
Pancreatic Cancer
Ribozar for Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Ribozar for Injection is indicated for patients previously treated with 5-FU.
How should I use Ribozar?
Use Ribozar as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ribozar is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Ribozar at home, carefully follow the injection procedures taught to you by your health care provider.
Do not use Ribozar if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
If Ribozar accidentally spills on your skin, wash it off immediately with soap and water. Clean any areas (tables, counter) where Ribozar may have spilled or sprayed.
Keep this product, as well as syringes and needles, out of the reach of children and away from 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 Ribozar, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Ribozar.
Uses of Ribozar 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.
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Use: Labeled Indications
Breast cancer (metastatic): First-line treatment of metastatic breast cancer (in combination with paclitaxel) after failure of adjuvant chemotherapy that contained an anthracycline (unless anthracyclines are contraindicated).
Non-small cell lung cancer (inoperable, locally advanced, or metastatic): First-line treatment (in combination with cisplatin) of inoperable, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC).
Ovarian cancer (advanced): Treatment of advanced ovarian cancer (in combination with carboplatin) that has relapsed at least 6 months following completion of platinum-based chemotherapy.
Pancreatic cancer (locally advanced or metastatic): First-line treatment of locally advanced (nonresectable stage II or III) or metastatic (stage IV) pancreatic adenocarcinoma. Ribozar is indicated for patients previously treated with fluorouracil.
Guideline recommendations:
Metastatic pancreatic cancer: American Society of Clinical Oncology (ASCO) guidelines for metastatic pancreatic cancer (ASCO [Sohal 2018]) recommend Ribozar (in combination with paclitaxel [protein bound]) as first-line therapy in patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, a relatively favorable comorbidity profile, a preference for relatively aggressive therapy, and a suitable support system. First-line therapy with single-agent Ribozar is recommended in patients with ECOG performance status of 2 or a comorbidity profile prohibiting more aggressive therapy when there is a preference for cancer-directed therapy; capecitabine or erlotinib (added to Ribozar) may also be offered in this situation. Ribozar (in combination with paclitaxel [protein bound]) may be utilized as second-line therapy in patients who received first-line FOLFIRINOX therapy, have an ECOG performance status of 0 or 1, have a relatively favorable comorbidity profile, a preference for aggressive therapy, and a suitable support system. Second-line therapy with Ribozar (alone) may also be considered as an option in patients with ECOG performance status of 2 or a comorbidity profile prohibiting more aggressive regimens when there is a preference to pursue cancer-directed therapy.
Locally advanced, unresectable pancreatic cancer: According to the ASCO guidelines for locally advanced, unresectable pancreatic cancer (ASCO [Balaban 2016]), induction with 6 months of initial systemic therapy (with a combination regimen) is generally recommended, although there is not enough evidence to encourage one regimen over another, and Ribozar-based therapies recommended in the metastatic setting have not been evaluated in randomized controlled studies for locally advanced unresectable pancreatic cancer. If disease progression occurs, treatment according to guidelines for metastatic pancreatic cancer should be offered.
Off Label Uses
Bladder cancer (advanced or metastatic)
Data from a large phase 3, randomized study support the use of Ribozar (in combination with cisplatin) for the treatment of advanced or metastatic bladder cancer.
Ribozar description
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Ribozar hydrochloride is 2'-deoxy-2', 2'- difluorocytidine monohydrochloride (beta-isomer). It has a molecular formula of C9H11F2N3O4·HCl and molecular weight of 299.66.
DBL Ribozar for Injection is a white to off-white lyophilised powder to be reconstituted for intravenous use.
Reconstituted solutions are both clear and colourless to pale yellow.
Each vial contains Gemcitabine hydrochloride.
Excipients/Inactive ingredients: Mannitol, sodium acetate, hydrochloric acid and sodium hydroxide.
Ribozar dosage
Ribozar is for IV use only.
Pancreatic Cancer: Ribozar should be administered by IV infusion at a dose of 1000 mg/m2 over 30 min once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequently, each cycle consists of once-a-week administration for 3 consecutive weeks, followed by a rest of 1 week.
Dose Modifications: Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient.
A full blood count should be performed prior to each course of Ribozar and every other week on therapy. A dose reduction of Ribozar is advised for myelotoxicity as given in the table.
Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine should be performed prior to initiation of therapy and periodically thereafter. Ribozar should be administered with caution in patients with evidence of significant renal or hepatic impairment.
If the recommended dose is well tolerated during the 1st cycle, [absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively], the dose may be increased to 1250 mg/m2 for the next cycle and, if well tolerated, it can be increased further to 1500 mg/m2.
Non-Small Cell Lung Cancer: Two treatment schedules have been tried with Ribozar; however, the optimum schedule has not been determined. With 4-week schedule, Ribozar should be administered IV at 1000 mg/m2 over 30 min on days 1, 8 and 15 of each 28-day cycle. Cisplatin should be administered IV at 100 mg/m2 on day 1 after the infusion of Ribozar. With the 3-week schedule, Ribozar should be administered IV at 1250 mg/m2 over 30 min on days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered IV after the infusion of Ribozar on day 1.
Dose Modifications: Dosage adjustments for hematologic toxicity may be required for Ribozar and for cisplatin. Ribozar dose adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Ribozar should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in the previous table.
In case of developing severe (grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Ribozar plus cisplatin should be held or decreased by 50%. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium and serum magnesium should be carefully monitored (grade 3/4 serum creatinine toxicity for Ribozar plus cisplatin was 5% vs 2% for cisplatin alone).
Ribozar can be administered on an outpatient basis.
No confirmed interactions have been reported with the use of Ribozar. No specific drug interaction studies of Ribozar's compatibility with other drugs have been conducted.
Useful Interactions: Ribozar has been studied extensively in combination with other agents eg, cisplatin in non-small cell lung cancer (NSCLC) and doxorubicin, epirubicin and taxol in breast cancer.
Cisplatin: There is a strong rationale for combining Ribozar with cisplatin, in particular in the treatment of NSCLC, as Ribozar has a unique mechanism of action and a mild toxicity profile that does not overlap with cisplatin. Moreover, in vivo and in vitro experimental data suggest the synergistic interaction of Ribozar-cisplatin combination. And also, in vivo studies have shown that human tumor xenografts, which are resistant to cisplatin or vindesine, have not acquired resistance to Ribozar.
Radiation Therapy: Experiments with mouse mammary tumor cells, colon tumor cells and pancreatic tumor cells have shown Ribozar to be a potent radiosensitizer. However, in clinical trials, use of Ribozar in patients with NSCLC and squamous cell carcinoma of the head and neck demonstrated significant toxicity particularly in patients receiving large volumes of radiotherapy. Safe and effective regimens for the administration of Ribozar with therapeutic doses of radiation have not yet been determined.
Hypoplasia of bone marrow (myelosuppression) is the principal dose-limiting effect with Ribozar therapy. Anemia, leukopenia, thrombocytopenia and other hematologic disorders have been reported in various studies. However, the overall hematologic toxicity of Ribozar must be considered modest, even with higher dose of Ribozar.
Mild blood loss and petechiae have occurred with Ribozar therapy. The overall hematologic toxicity of Ribozar must be considered modest, even with higher doses of Ribozar.
In general, thrombocytopenia has been a mild effect of Ribozar therapy. The incidence of thrombocytopenia has been low (≤1.2% of patients), with mild symptoms, which have not been clinically significant. In addition, no signs or symptoms of cumulative toxicity have been observed in frequent reports of cardiac disorders that include dysrythmias, myocardial infarction and congestive heart failure have been associated with Ribozar therapy. Capillary leak syndrome, hypertension and edema have also been reported. Isolated cases of severe hypertension and edema have been reported during Ribozar therapy. Paresthesias, somnolence have been reported with therapeutic use. Fever has been reported frequently with therapeutic use and generally not associated with clinical infection. Nausea, vomiting, diarrhea, constipation and mucous membrane disorders have been reported following routine Ribozar therapy. Proteinuria and hematuria are frequently reported with Ribozar therapy. Nephrotoxicity and hemolytic uremic syndrome have been rarely reported. Transient elevations of serum transaminases have occurred frequently with patients, but patients remained asymptomatic. Mild dyspnea has been reported frequently following therapy. Several cases of pneumonitis, pulmonary hemorrhage and fatal pulmonary toxicity manifesting as adult respiratory distress syndrome (ARDS) have also occurred. Alopecia and rashes seem to occur relatively frequently during Ribozar therapy. Case reports of pruritus, radiation recall dermatitis, erythema, skin ulcerations and pseudolymphoma have been noted with patients. Asthenia and bone pain has occurred with Ribozar therapy.
Hypersensitivity to Ribozar or to any of the other ingredients of Hospira Ribozar.
Use in pregnancy: Category D: Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Hospira Ribozar must not be used during pregnancy.
Studies in experimental animals (mice and rabbits at doses up to 4.5 and 1.6 mg/m2/day IV respectively, administered during the period of organogenesis) have shown teratogenicity and embryotoxicity. Peri- and post-natal studies in mice at doses up to 4.5 mg/m2/day have shown retarded physical development in the offspring.
Women of childbearing age receiving Ribozar should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
The results of a survey conducted on ndrugs.com for Ribozar 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 Ribozar. 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.
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