Epogen: Drug Information and Side Effects

Manufactured by Amgen Inc., Epogen is a man-made protein of erythropoietin, called epoetin alfa. Erythropoietin is a glycoprotein produced in the kidneys which stimulates red blood cell production.

A 165 amino acid glycoprotein made by genetically engineering DNA, Epogen has the same biological effects as natural erythropoietin. With a molecular weight of 30,400 daltons and it contains the identical amino acid sequence of isolated natural erythropoietin.

Epogen is prepared as a sterile, colorless liquid in an isotonic sodium chloride/ sodium citrate buffered solution or a sodium chloride/ sodium phosphate buffered solution for intravenous or subcutaneous administration. It is available in both single and multi dose vials of various dosages.

Single-Dose, Preservative - Free Vial

Each 1 mL of solution contains 2000, 3000, 4000 or 10,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 5.8 mg sodium citrate, 5.8 mg sodium chloride, and 0.06 mg citric acid in Water for Injection, USP (pH 6.9 ± 0.3). This formulation contains no preservative.

Single -Dose, Preservative-Free Vial - 1 mL (40,000 Units/ mL)

Each 1 mL of solution contains 40,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.2 mg sodium phosphate monobasic monohydrate, 1.8 mg sodium phosphate dibasic anhydrate, 0.7 mg sodium citrate, 5.8 mg sodium chloride, and 6.8 mg citric acid in Water for Injection, USP (pH 6.9 ± 0.3). This formulation contains no preservative.

Multidose, Preserved Vial - 2 mL (20,000 Units, 10,000 Units/ mL)

Each 1 mL of solution contains 10,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.3 mg sodium citrate, 8.2 mg sodium chloride, 0.11 mg citric acid, and 1% benzyl alcohol as preservative in Water for Injection, USP (pH 6.1 ± 0.3).

Multidose, Preserved Vial- 1 mL (20,000 Units/ mL)

Each 1 mL of solution contains 20,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.3 mg sodium citrate, 8.2 mg sodium chloride, 0.11 mg citric acid, and 1% benzyl alcohol as preservative in Water for Injection, USP (pH 6.1 ± 0. 3).

Before using Epogen, it is important that you discuss its health benefits with your doctor.

You need to inform your doctor if you have ever had any unusual or allergic reaction to epoetin or to human albumin, or if you are allergic to any other substances, such as foods, preservatives, or dyes. You will also need to inform your doctor if you are pregnant, plan to become pregnant or are breast feeding, as Epogen has not been studied in pregnant women and children under the age of 18.

The presence of other medical problems may affect the use of Epogen.

Inform your doctor if you have any of the following medical problems;

• Aluminum poisoning
• Blood clots or other problems with the blood
• Folic acid, iron, or vitamin B12 deficiencies
• Heart or blood vessel disease
• Heart attacks
• Heart bypass surgery
• High blood pressure
• Thrombosis
• Infection, inflammation, or cancer
• Bone problems
• Porphyrin (red blood cell pigment) metabolism disorder
• Sickle cell anemia or
• Seizures

Precautions

Epogen sometimes causes seizures during the first 90 days of treatment. For this period it is best to avoid driving, operating heavy machinery, or performing any other hazardous activities. It is important to remember that Epogen only corrects anemia, it does not affect kidney disease or any other medical problem. Epogen can cause uncontrolled hypertension, it is important that you take this drug under a doctor’s supervision.

Side Effects

Epogen is usually well-tolerated in most people, but like all drugs it also causes certain side effects for some.
Common side effects in patients with kidney failure on dialysis are;

• high blood pressure
• headache
• joint-pain and
• blood clots at the site of injection

In HIV-infected patients receiving zidovudine, the most common side effects of Epogen are;

• fever
• headache
• rash, and
• nasal or chest congestion

The most common side effects in patients undergoing surgery with anemia on Epogen are;

• fever
• anxiousness and
• deep venous thrombosis - blood clots in the vein

In cancer patients on chemotherapy, the most common side effects include;

• fever
• diarrhea,
• tissue swelling
• shortness of breath
• paresthesia (abnormal burning or prickling sensations anywhere in the body) and
• upper respiratory infections

Most of these side effects usually go away during treatment but if they continue to be bothersome it is important to call your doctor.