mitoxantrone

ROUTE	ONSET	PEAK	DURATION
IV	unknown	10 days	21 days

Contraindicated in:

Hypersensitivity;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Cardiovascular disease (↑ risk of HF);
Active infection;
↓bone marrow reserve;
Previous mediastinal radiation or use of anthracyclines (↑ risk of HF);
Impaired hepatobiliary function;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may have sensitivity to drug effects.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmias, ECG changes, HF

Derm: alopecia, rash

EENT: blue-green sclera, conjunctivitis

GI: abdominal pain, diarrhea, hepatotoxicity, nausea, stomatitis, vomiting

GU: blue-green urine, gonadal suppression, renal failure

Hemat: anemia, leukopenia, thrombocytopenia, SECONDARY LEUKEMIA

Metab: hyperuricemia

Neuro: headache, SEIZURES

Resp: cough, dyspnea

Misc: fever, HYPERSENSITIVITY REACTIONS

Interactions ⬆ ⬇

Drug-drug:

↑bone marrow depression with other antineoplastics or radiation therapy.
Risk of cardiomyopathy↑ by previous anthracycline antineoplastics (daunorubicin, doxorubicin, idarubicin) or mediastinal radiation.
May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.

Route/Dosage ⬆ ⬇

Acute Nonlympocytic Leukemia

IV (Adults ): Induction: 12 mg/m²/day for 3 days (usually given with cytosine arabinoside 100 mg/m²/day for 7 days); if incomplete remission occurs, a 2nd induction may be given. Consolidation: 12 mg/m²/day for 2 days (usually given with cytosine arabinoside 100 mg/m²/day for 5 days), given 6 wk after induction with another course 4 wk later.

Advanced Prostate Cancer

IV (Adults ): 12–14 mg/m² as single dose (with corticosteroids).

Multiple Sclerosis

IV (Adults ): 12 mg/m² every 3 mo.

Availability ⬆ ⬇

(Generic available)

Solution for injection: 2 mg/mL

Assessment ⬆ ⬇

Monitor for hypersensitivity reaction (rash, urticaria, bronchospasm, tachycardia, hypotension, wheezing, tightness in chest or throat, swelling of mouth, face, lips, tongue, or throat). If these occur, stop infusion and notify health care professional. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae, guaiac stools, urine, and emesis) and avoid IM injections and taking rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
Monitor intake and output, appetite, and nutritional intake. Assess patient for nausea and vomiting. Antiemetics may be administered prophylactically. Adjust diet as tolerated to help maintain fluid and electrolyte balance and nutritional status.
Monitor chest x-ray, ECG, echocardiography or MUGA, and radionuclide angiography to determine ejection fraction prior to and periodically during therapy. Multiple sclerosis patients with baseline left ventricular ejection fraction (LVEF)<50% should not receive mitoxantrone. May cause cardiotoxicity, especially in patients who have received daunorubicin or doxorubicin. Assess for rales/crackles, dyspnea, edema, jugular vein distention, ECG changes, arrhythmias, and chest pain. Monitor LVEF with echocardiogram or MUGA if signs of HF occur, prior to each dose, and yearly after stopping therapy in patients with multiple sclerosis. Potentially fatal HF may occur during or for mo or years after therapy. Risk is greater in patients receiving a cumulative dose >140 mg/m².
Monitor for symptoms of gout (↑ uric acid levels and joint pain and swelling). Encourage patient to drink at least 2 L of fluid per day. Allopurinol may be given to decrease serum uric acid levels.
Multiple sclerosis: Asses frequency of exacerbations of symptoms of multiple sclerosis periodically during therapy.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy.
Monitor CBC with differential and platelet count prior to and periodically during therapy. The nadir of leukopenia usually occurs within 10 days, and recovery usually occurs within 21 days.
- Monitor liver function studies (AST, ALT, LDH, bilirubin) and renal function studies (BUN, serum creatinine) prior to and periodically during therapy to detect hepatotoxicity and nephrotoxicity.
- May cause ↑ uric acid concentrations. Monitor periodically during therapy.

Implementation ⬆ ⬇

Do not confuse mitoxantrone with mitomycin or MTX Patch (lidocaine/menthol).
There are lifetime maximum doses for mitoxantrone. Check manufacturer's information and patient history before administering.
Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard equipment in designated containers.
- Avoid contact with skin. Use Luer-Lok tubing to prevent accidental leakage. If contact with skin occurs, immediately wash skin with soap and water.
- Clean all spills with an aqueous solution of calcium hypochlorite. Mix solution by adding 5.5 parts (per weight) of calcium hypochlorite to 13 parts water.

IV Administration:

IV: Monitor IV site. Mitoxantrone is an irritant with vesicant-like properties. Administer only into a free-flowing IV; may cause severe local tissue damage if extravasation occurs. Ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation. If extravasation occurs, discontinue IV and restart at another site. Elevate extremity with extravasation and place ice packs over area. Monitor closely and obtain surgical consultation if local reaction occurs.
Diluent: Dilute dark blue mitoxantrone solution in at least 50 mL of 0.9% NaCl or D5W. Discard unused solution appropriately.
Rate: Administer slowly over at least 3 min into the tubing of a free-flowing IV of 0.9% NaCl or D5W.
Intermittent Infusion: May be further diluted in D5W, 0.9% NaCl, or D5/0.9% NaCl and used immediately. Concentration: 0.02–0.5 mg/mL. Open vials may be stored at room temperature for 7 days or under refrigeration for up to 14 days. Solutions diluted in D5W or 0.9% NaCl are stable for up to 7 days at room temperature or under refrigeration; manufacturer recommends immediate use.
Rate: Administer over 15–30 min.

Patient/Family Teaching ⬆ ⬇

Advise patient to read the Patient Package Insert before starting therapy and before each dose in case of changes. Explain purpose of mitoxantrone to patient.
Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; increased fatigue; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
Instruct patient to notify health care professional if abdominal pain, yellow skin, cough, diarrhea, or decreased urine output occurs.
Inform patient that medication may cause the urine and sclera to turn blue-green.
Instruct patient to inspect oral mucosa for redness and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Topical agents may be used if pain interferes with eating. Stomatitis pain may require treatment with opioid analgesics.
Discuss with patient the possibility of hair loss. Explore coping strategies.
Instruct patient not to receive any vaccinations without advice of health care professional.
Rep: May cause fetal harm. Refer patient to a facility with expertise in cancer during pregnancy. Advise patient that although mitoxantrone may cause infertility, contraception during therapy is necessary because of possible fetal harm. Discontinue breastfeeding before starting mitoxantrone.
Emphasize need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in the production and spread of leukemic cells.
Decreased pain in patients with prostate cancer.
Decrease disability and slowed progression of MS.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0703- Teva Parenteral Medicines, Inc.
- 0703-4680- mitoXANTRONE
  - 0703-4680-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4680-01) > 12.5 mL in 1 VIAL, MULTI-DOSE

0703- Teva Parenteral Medicines, Inc.
- 0703-4685- mitoXANTRONE
  - 0703-4685-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4685-01) > 10 mL in 1 VIAL, MULTI-DOSE

0703- Teva Parenteral Medicines, Inc.
- 0703-4686- mitoXANTRONE
  - 0703-4686-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4686-01) > 15 mL in 1 VIAL, MULTI-DOSE

61703- Hospira, Inc.
- 61703-343- Mitoxantrone
  - 61703-343-18- 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) > 10 mL in 1 VIAL, MULTI-DOSE

61703- Hospira, Inc.
- 61703-343- Mitoxantrone
  - 61703-343-65- 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) > 12.5 mL in 1 VIAL, MULTI-DOSE

61703- Hospira, Inc.
- 61703-343- Mitoxantrone
  - 61703-343-66- 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) > 15 mL in 1 VIAL, MULTI-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-132- Mitoxantrone
  - 63323-132-10- 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) > 10 mL in 1 VIAL, MULTI-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-132- Mitoxantrone
  - 63323-132-12- 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) > 12.5 mL in 1 VIAL, MULTI-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-132- Mitoxantrone
  - 63323-132-15- 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) > 15 mL in 1 VIAL, MULTI-DOSE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇