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RYANODEX®

(dantrolene sodium) for injectable suspension

Indications and Important Safety Information

Indications
RYANODEX® (dantrolene sodium) for injectable suspension is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.

Important Safety Information
RYANODEX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including discontinuing use of MH-triggering anesthetic agents, managing the metabolic acidosis, instituting cooling when necessary, and administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis).

RYANODEX® is associated with skeletal muscle weakness such as loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis.

BENDEKA®

(bendamustine hydrochloride) Injection

Indications and Important Safety Information

Indications
BENDEKA is indicated for the treatment of patients with Chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information
Contraindication: BENDEKA® (bendamustine HCI) injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine HCl, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Myelosuppression: Bendamustine HCl caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with bendamustine HCl are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment measures prior to administration.

Anaphylaxis and Infusion Reactions: Infusion reactions to bendamustine HCl have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with bendamustine HCl has occurred. The onset tends to be within the first treatment cycle with bendamustine HCl and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when bendamustine HCl and allopurinol are administered concomitantly.

Skin Reactions: Fatal and serious skin reactions have been reported with bendamustine HCl and include, toxic skin reactions, [Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)], bullous exanthema and rash. Events occurred when bendamustine HCl was given as a single agent and in combination with other anticancer agents or allopurinol. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue BENDEKA.

Hepatotoxicity: Fatal and serious cases of liver injury have been reported with bendamustine HCl. Combination therapy, progressive disease or reactivation of hepatitis B were confounding factors in some patients. Most cases were reported within the first three months of starting therapy. Monitor liver chemistry tests prior to and during BENDEKA therapy.

Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine HCl, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA has not been determined.

Extravasation Injury: Bendamustine HCl extravasations have been reported in post-marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting BENDEKA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.

Embryo-fetal Toxicity: Bendamustine HCl can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.

Most Common Adverse Reactions:
Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue.
Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

BENDAMUSTINE

Hydrochloride Injection

Indications and Important Safety Information

Indications
Bendamustine Hydrochloride Injection is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
Bendamustine Hydrochloride Injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information
Contraindications: Bendamustine Hydrochloride Injection is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. Reactions to Bendamustine Hydrochloride have included anaphylaxis and anaphylactoid reactions.

Myelosuppression: Bendamustine Hydrochloride caused severe myelosuppression (Grade 3-4) in 98% of patients in the 2 NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. In the event of treatment-related myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the absolute neutrophil count (ANC) should be ≥1 x 109/L and the platelet count should be ≥75 x 109/L.

Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis, and death has occurred in adult and pediatric patients in clinical trials and in postmarketing reports for Bendamustine Hydrochloride. Patients with myelosuppression following treatment with Bendamustine Hydrochloride are more susceptible to infections. Advise patients with myelosuppression following Bendamustine Hydrochloride treatment to contact a physician immediately if they have symptoms or signs of infection. Patients treated with Bendamustine Hydrochloride are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate measures (including clinical and laboratory monitoring, prophylaxis, and treatment) for infection and infection reactivation prior to administration.

Anaphylaxis and Infusion Reactions: Infusion reactions to Bendamustine Hydrochloride have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Patients who experience Grade 3 or worse allergic-type reactions should not be rechallenged. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions. Discontinue Bendamustine Hydrochloride for patients with Grade 4 infusion reactions. Consider discontinuation for Grade 3 infusion reactions as clinically appropriate considering individual benefits, risks, and supportive care.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with Bendamustine Hydrochloride has occurred in patients in clinical trials and in postmarketing reports. The onset tends to be within the first treatment cycle of Bendamustine Hydrochloride and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of Bendamustine Hydrochloride therapy. However, there may be an increased risk of severe skin toxicity when Bendamustine Hydrochloride and allopurinol are administered concomitantly.

Skin Reactions: Fatal and serious skin reactions have been reported with Bendamustine Hydrochloride treatment in clinical trials and postmarketing safety reports, including toxic skin reactions [Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)], bullous exanthema, and rash. Events occurred when Bendamustine Hydrochloride was given as a single agent and in combination with other anticancer agents or allopurinol.
Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue Bendamustine Hydrochloride.

Hepatotoxicity: Fatal and serious cases of liver injury have been reported with Bendamustine Hydrochloride Injection. Combination therapy, progressive disease, or reactivation of hepatitis B were confounding factors in some patients. Most cases were reported within the first 3 months of starting therapy. Monitor liver chemistry tests prior to and during Bendamustine Hydrochloride therapy.

Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with Bendamustine Hydrochloride, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma.

Extravasation Injury: Bendamustine Hydrochloride extravasations resulting in hospitalizations from erythema, marked swelling, and pain have been reported in postmarketing. Ensure good venous access prior to starting Bendamustine Hydrochloride infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of Bendamustine Hydrochloride.

Embryo-fetal Toxicity: Bendamustine Hydrochloride can cause fetal harm when administered to a pregnant woman. Single intraperitoneal doses of bendamustine in mice and rats administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations, and decreased fetal body weights. Advise women to avoid becoming pregnant while using Bendamustine Hydrochloride.

Most Common Adverse Reactions

Most common non-hematologic adverse reactions (any grade) for CLL (frequency >15%) were pyrexia (24%), nausea (20%), and vomiting (16%).
Most common non-hematologic adverse reactions for NHL (frequency ≥30%) were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%), and pyrexia (34%).
The most common non-hematologic Grade 3 or 4 adverse reactions (≥5%) were fatigue (11%); febrile neutropenia (6%); and pneumonia, hypokalemia, and dehydration, each reported in 5% of patients.

TO REPORT ADVERSE REACTIONS, contact Eagle at 1‑855-318-2170 or drugsafety@eagleus.com.

DOCETAXEL INJECTION

(non-alcohol formula)

Please see full Prescribing Information for boxed warning.

ARGATROBAN

(Argatroban Injection)

WHERE OTHERS SEE A
STOPPING POINT,
WE SEE UNTAPPED
POTENTIAL.

We believe that making the best end product
starts at the beginning. This is why we use our
3-step process of reinvention to see products
through from start to finish.

1

Identify medicines that can benefit from second generation advancements

2

Improve products by determining the technology requirements to address unmet needs

3

Impact patients’ lives with improved medicines brought to market primarily through the 505(b)(2) regulatory pathway

Through a fully integrated commercial team, we have the flexibility to market our products with or without a partner.

REFERENCES:

  1. RYANODEX® (dantrolene sodium) for injectable suspension [package insert]. Woodcliff Lake, NJ: Eagle Pharmaceuticals, Inc.; 2017.
  2. BENDEKA® (bendamustine hydrochloride) injection [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2017.
  3. Bendamustine Hydrochloride Injection Prescribing Information. Woodcliff Lake, NJ: Eagle Pharmaceuticals, Inc. 2018.