Nabigem Uses

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What is Nabigem?

Nabigem 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).

Nabigem 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.

Nabigem 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.

Nabigem 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 Nabigem has been stopped.

This medicine is to be given only by or under the direct supervision of your doctor.

Nabigem 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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Non-Small Cell Lung Cancer: First-line treatment, alone or in combination with cisplatin for locally advanced or metastatic non-small cell lung cancer.

Pancreatic Cancer: Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer.

Bladder Cancer: Treatment of patients with bladder cancer.

Breast Cancer: Treatment of patients with advanced breast cancer; treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy (Nabigem in combination with paclitaxel) or following chemotherapy for metastatic disease (Nabigem in monotherapy). Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

Cervical Cancer: In combination, a first-line treatment of patients with locally advanced or metastatic cervical cancer.

Ovarian Cancer: First-line therapy in combination with carboplatin for locally advanced or metastatic epithelial ovarian carcinoma in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based.

Other Therapeutic Activity: Nabigem alone or in combination has shown activity in renal cancer.

Nabigem has shown some activity in advanced small cell lung cancer and advanced refractory testicular cancer.

How should I use Nabigem?

Use Nabigem as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Nabigem is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Nabigem at home, carefully follow the injection procedures taught to you by your health care provider.
  • Do not use Nabigem if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • If Nabigem accidentally spills on your skin, wash it off immediately with soap and water. Clean any areas (tables, counter) where Nabigem 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 Nabigem, 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 Nabigem.

Uses of Nabigem 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. Nabigem 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 Nabigem (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 Nabigem 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 Nabigem) may also be offered in this situation. Nabigem (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 Nabigem (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 Nabigem-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 Nabigem (in combination with cisplatin) for the treatment of advanced or metastatic bladder cancer.

Nabigem description

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Nabigem 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 Nabigem 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.

Nabigem dosage

Nabigem is for IV use only.

Pancreatic Cancer: Nabigem 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 Nabigem and every other week on therapy. A dose reduction of Nabigem 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. Nabigem 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 Nabigem; however, the optimum schedule has not been determined. With 4-week schedule, Nabigem 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 Nabigem. With the 3-week schedule, Nabigem 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 Nabigem on day 1.

Dose Modifications: Dosage adjustments for hematologic toxicity may be required for Nabigem and for cisplatin. Nabigem dose adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Nabigem 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 Nabigem 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 Nabigem plus cisplatin was 5% vs 2% for cisplatin alone).

Nabigem can be administered on an outpatient basis.

Nabigem interactions

See also:
What other drugs will affect Nabigem?

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Radiotherapy: Concurrent (Given Together or Equal to or 7 Days Apart): Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of Nabigem, frequency of Nabigem administration, dose of radiation, radiotherapy planning technique, the target tissue and target volume. In a single trial where Nabigem at a dose of 1,000 mg/m2 was administered concurrently for up to 6 consecutive weeks with therapeutic thoracic radiation to patients with NSCLC, significant toxicity in the form of severe and potentially life-threatening, esophagitis and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy (median treatment volumes 4,795 cm3). The optimum regimen for safe administration of Nabigem with therapeutic doses of radiation has not yet been determined.

Radiation injury has been reported on targeted tissues (eg, esophagitis, colitis and pneumonitis) in association with both concurrent and noncurrent use of Nabigem.

When given in combination with paclitaxel, cisplatin or carboplatin, the pharmacokinetics of Nabigem were not altered. Nabigem had no effect on paclitaxel pharmacokinetics.

Laboratory Tests: Therapy should be started cautiously in patients with compromised bone marrow function. As with other oncolytics, the possibility of cumulative bone marrow suppression when using combination or sequential chemotherapy should be considered.

Patients receiving Nabigem should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. Suspension or modification of therapy should be considered when drug-induced marrow depression is detected. For guidelines regarding dose modifications, see Dosage & Administration. Peripheral blood counts may continue to fall after the medicine is stopped.

Laboratory evaluation of renal and hepatic function should be performed periodically. Raised liver transaminases (AST/ALT) and alkaline phosphatase are seen in approximately 60% of the patients. These increases are usually mild, transient and not progressive and seldom lead to cessation of treatment. Increased bilirubin (WHO toxicity degrees 3 and 4) was observed in 2.6% of the patients. Hospira Nabigem should be given with caution to patients with impaired hepatic function.

Administration of Nabigem in patients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency.

A few cases of renal failure, including hemolytic uremic syndrome have been reported.

Nabigem should be administered with caution to patients with impaired renal function. Hospira Nabigem treatment should be withdrawn if there is any sign of microangiopathic hemolytic anemia eg, rapidly falling hemoglobin levels with simultaneous thrombocytopenia, elevation of serum bilirubin, serum creatinine, urea or lactate dehydrogenase (LDH). Renal failure may be irreversible despite withdrawal of Hospira Nabigem treatment and may require dialysis.

Nabigem side effects

See also:
What are the possible side effects of Nabigem?

Hypoplasia of bone marrow (myelosuppression) is the principal dose-limiting effect with Nabigem therapy. Anemia, leukopenia, thrombocytopenia and other hematologic disorders have been reported in various studies. However, the overall hematologic toxicity of Nabigem must be considered modest, even with higher dose of Nabigem.

Mild blood loss and petechiae have occurred with Nabigem therapy. The overall hematologic toxicity of Nabigem must be considered modest, even with higher doses of Nabigem.

In general, thrombocytopenia has been a mild effect of Nabigem 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 Nabigem therapy. Capillary leak syndrome, hypertension and edema have also been reported. Isolated cases of severe hypertension and edema have been reported during Nabigem 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 Nabigem therapy. Proteinuria and hematuria are frequently reported with Nabigem 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 Nabigem 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 Nabigem therapy.

Nabigem contraindications

See also:
What is the most important information I should know about Nabigem?

Do not receive Nabigem if you are pregnant. It could harm the unborn baby.

Nabigem is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Nabigem is usually given once a week for several weeks. The medicine must be given slowly, and the IV infusion can take up to 30 minutes to complete.

Nabigem can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be checked. Do not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with Nabigem, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.



Active ingredient matches for Nabigem:

Gemcitabine in Argentina.


List of Nabigem substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
1 g x 50ml (Cipla Limited)$ 91.98
1.4 g x 50ml (Cipla Limited)$ 134.92
200 mg x 10ml (Cipla Limited)$ 22.14
Oncogem 1g VIAL / 50ml (Cipla Limited)$ 91.98
Oncogem 1.4g VIAL / 50ml (Cipla Limited)$ 134.92
Oncogem 200mg VIAL / 10ml (Cipla Limited)$ 22.14
Oncogem 1000 mg Injection (Cipla Limited)$ 0.08
Oncogem 200 mg Injection (Cipla Limited)$ 0.02
ONCOGEM 1.4GM INJECTION 1 vial / 20 ML injection each (Cipla Limited)$ 166.06
ONCOGEM inj 1 g x 50ml (Cipla Limited)$ 91.98
ONCOGEM inj 1.4 g x 50ml (Cipla Limited)$ 134.92
ONCOGEM inj 200 mg x 10ml (Cipla Limited)$ 22.14
Oncogem 1.4gm Injection (Cipla Limited)$ 8.30
Oncoril / vial 1 g x 1's (Ambica)
TABICAD 1000MG INJECTION 1 vial / 1 injection each (Cadila Pharmaceuticals Ltd)$ 51.59
TABICAD 200MG INJECTION 1 vial / 1 injection each (Cadila Pharmaceuticals Ltd)$ 22.08
Tabicad 200mg Injection (Cadila Pharmaceuticals Ltd)$ 22.08
WINOGEM 1.4GM INJECTION 1 vial / 1 injection each (Wockhardt Ltd)$ 122.08

References

  1. PubChem. "gemcitabine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "gemcitabine". http://www.drugbank.ca/drugs/DB00441 (accessed September 17, 2018).
  3. MeSH. "Radiation-Sensitizing Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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