FDA

Etopophos Preservative Free

Approved 17 May 1996InjectionInjectable

The FDA lists this product in 3 strengths and forms.

Indications

ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1 )

1.1Refractory Testicular Tumors

ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors.

1.2Small Cell Lung Cancer

ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.

Contraindications

ETOPOPHOS is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see Warnings and Precautions (5.3) ] . Hypersensitivity to etoposide products. ( 4 , 5.3 )

Warnings and precautions

Myelosuppression : Obtain complete blood counts prior to each cycle and more frequently as clinically indicated. ( 5.1 ) Secondary leukemias : Can occur with long-term use. ( 5.2 ) Hypersensitivity reactions : Hypersensitivity reactions including anaphylaxis may occur. ( 5.3 ) Embryo-fetal toxicity : ETOPOPHOS can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with ETOPOPHOS and for 6 months after final dose.

Advise males to use effective contraception for 4 months, after the last dose of ETOPOPHOS. ( 5.4 , 8.1 , 8.3 )

5.1Myelosuppression

ETOPOPHOS causes myelosuppression that results in thrombocytopenia and neutropenia. Fatal infections and bleeding have occurred. Obtain complete blood counts prior to each cycle of ETOPOPHOS and more frequently as clinically indicated [see Adverse Reactions (6.1)] .

Indications

1.1Refractory Testicular Tumors

ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors.

1.2Small Cell Lung Cancer

ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.

Warnings and precautions

Advise males to use effective contraception for 4 months, after the last dose of ETOPOPHOS. ( 5.4 , 8.1 , 8.3 )

5.1Myelosuppression

Adverse reactions

The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Secondary leukemias [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Most common adverse reaction is neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-866-885-0690 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials 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 practice. ETOPOPHOS has been used as a single agent in clinical studies involving 206 patients with a variety of malignancies (including one non-Hodgkin’s lymphoma) and in combination with cisplatin in 60 patients with small cell lung cancer.

The most common adverse reaction was neutropenia. Other Important Adverse Reactions Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of nausea and vomiting is generally mild to moderate, with treatment discontinuation required in 1% of patients. Nausea and vomiting are managed with standard antiemetic therapy. Other Toxicities Other clinically important adverse reactions in clinical trials were: Gastrointestinal: abdominal pain, constipation, dysphagia General: fever Ocular: transient cortical blindness, optic neuritis Respiratory: interstitial pneumonitis/pulmonary fibrosis Skin: pigmentation, radiation recall dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis Neurologic: seizure, aftertaste Hepatobiliary disorder: hepatotoxicity

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ETOPOPHOS. 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. Extravasation Extravasation, resulting in local soft tissue toxicity. Extravasation of ETOPOPHOS can result in swelling, pain, cellulitis, and necrosis, including skin necrosis.

Acute Renal Failure Reversible cases of acute renal failure have been reported with administration of high dose (2220 mg/m 2 ) ETOPOPHOS with total body irradiation used for hematopoietic stem cell transplantation. The ETOPOPHOS formulation contains dextran 40, which has been associated with acute renal failure when administered in high doses.

Etopophos Preservative Free

Indications

1.1Refractory Testicular Tumors

1.2Small Cell Lung Cancer

Contraindications

Warnings and precautions

5.1Myelosuppression

Two medicines in one question?

Etopophos Preservative Free

Indications

1.1Refractory Testicular Tumors

1.2Small Cell Lung Cancer

Contraindications

Warnings and precautions

5.1Myelosuppression

Two medicines in one question?

5.2Secondary Leukemias

5.3Hypersensitivity Reactions

5.4Embryo-Fetal Toxicity Based

Interactions

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance