Ifex


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Ifex

 [i´feks]
trademark for a preparation of ifosfamide, an antineoplastic agent.

ifosfamide

Ifex, Mitoxana (UK)

Pharmacologic class: Alkylating agent, nitrogen mustard

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Box Warning

• Give under supervision of physician experienced in using cancer chemotherapy, in facility with adequate diagnostic and treatment resources. Adverse urotoxic effects (especially hemorrhagic cystitis) and CNS toxicities (such as confusion and coma) have occurred; these effects may warrant drug discontinuation.

• Severe myelosuppression may occur.

Action

Alkylates DNA, interfering with replication and synthesis of susceptible cells and ultimately causing cell death

Availability

Injection: 1 g or 3 g in single-dose vials

Indications and dosages

Germ-cell testicular cancer

Adults: 1.2 g/m2/day by I.V. infusion over 30 minutes for 5 days. May repeat q 3 weeks or after recovery from hematologic toxicity.

Off-label uses

• Acute leukemia
• Breast, lung, ovarian, and pancreatic cancer
• Malignant lymphomas
• Sarcomas

Contraindications

• Hypersensitivity to drug
• Severe bone marrow depression
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• impaired renal or hepatic function, mild to moderate bone marrow depression.

Administration

• Follow facility policy for handling antineoplastic agents.
• Know that drug is usually given with other antineoplastics and hemorrhagic cystitis agent.
• To reconstitute, add sterile water or bacteriostatic water to vial, and shake gently.
• Mix 20 ml of diluent with 1-g vial or 60 ml of diluent with 3-g vial, to yield a concentration of 50 mg/ml. For smaller concentrations, dilute solution further with normal saline solution, dextrose 5% in water, lactated Ringer's solution, or sterile water.
• Administer I.V. slowly over at least 30 minutes.

Adverse reactions

CNS: drowsiness, confusion, ataxia, hallucinations, depressive psychosis, dizziness, disorientation, cranial nerve dysfunction, coma, seizures

CV: phlebitis

GI: nausea, vomiting, diarrhea, anorexia, stomatitis

GU: hematuria, bladder fibrosis, gonadal suppression, nephrotoxicity, hemorrhagic cystitis

Hematologic: anemia, leukopenia, thrombocytopenia, bone marrow depression

Metabolic: metabolic acidosis

Skin: alopecia

Other: infection, secondary neoplasms

Interactions

Drug-diagnostic tests.Hepatic enzymes, uric acid: increased levels

Platelets, white blood cells: decreased counts

Patient monitoring

• Monitor hematopoietic function tests (such as CBC with white cell differential) before therapy and weekly during therapy.
• Assess fluid intake and output. Ensure fluid intake of at least 2 L daily to prevent bladder toxicity.

Monitor urine output for hematuria and hemorrhagic cystitis. Administer mesna (protective drug), as indicated and prescribed.

Patient teaching

Tell patient to immediately report jaundice, unusual bleeding or bruising, bloody urine, pain on urination, fever, chills, sore throat, cough, difficulty breathing, unusual lumps or masses, mouth sores, or pain in flank, stomach, or joints.
• Instruct patient to maintain adequate hydration and nutrition. Advise him to drink 10 to 12 glasses of fluid each day.
• Inform patient that drug may cause hair loss.
• Advise both male and female patients to use reliable contraception during and immediately after therapy, because drug may cause severe birth defects.
• Urge patient to keep regular follow-up appointments for blood tests and monitoring of drug effects.
• As appropriate, review other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

ifosfamide

(eye-foss-fam-ide) ,

Ifex

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: alkylating agents
Pregnancy Category: D

Indications

Germ cell testicular carcinoma (with other agents).Used with mesna, which prevents ifosfamide-induced hemorrhagic cystitis.

Action

Following conversion to active compounds, interferes with DNA replication and RNA transcription, ultimately disrupting protein synthesis (cell-cycle phase–nonspecific).

Therapeutic effects

Death of rapidly replicating cells, particularly malignant ones.

Pharmacokinetics

Absorption: Administered IV only; inactive prior to conversion to metabolites.
Distribution: Excreted in breast milk.
Metabolism and Excretion: Metabolized by the liver to active antineoplastic compounds.
Half-life: 15 hr.

Time/action profile (effects on blood counts)

ROUTEONSETPEAKDURATION
IVunknown7–14 days21 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Patients with childbearing potential;Active infections;Decreased bone marrow reserve; Geriatric: Geriatric patients;Other chronic debilitating illness;Impaired renal function; Pediatric: Children.

Adverse Reactions/Side Effects

Central nervous system

  • CNS toxicity (somnolence, confusion, hallucinations, coma) (most frequent)
  • cranial nerve dysfunction
  • disorientation
  • dizziness

Cardiovascular

  • cardiotoxicity

Gastrointestinal

  • nausea (most frequent)
  • vomiting (most frequent)
  • anorexia
  • constipation
  • diarrhea
  • hepatotoxicity

Genitourinary

  • hemorrhagic cystitis (most frequent)
  • dysuria
  • sterility
  • renal toxicity

Dermatologic

  • alopecia (most frequent)

Hematologic

  • anemia
  • leukopenia
  • thrombocytopenia

Local

  • phlebitis

Miscellaneous

  • allergic reactions

Interactions

Drug-Drug interaction

↑ myelosuppression with other antineoplastics or radiation therapy.Toxicity may be ↑ by allopurinol or phenobarbital.May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines.

Route/Dosage

Other Regimens are Used
Intravenous (Adults) 1.2 g/m2/day for 5 days; coadminister with mesna. May repeat cycle q 3 wk.

Availability (generic available)

Injection: 1 g/vial, 3 g/vial
In combination with: In a kit with mesna.

Nursing implications

Nursing assessment

  • Monitor BP, pulse, respiratory rate, and temperature frequently during administration. Report significant changes.
  • Monitor urinary output frequently during therapy. Notify health care professional if hematuria occurs. To reduce the risk of hemorrhagic cystitis, fluid intake should be at least 3000 mL/day for adults and 1000–2000 mL/day for children. Mesna is given concurrently to prevent hemorrhagic cystitis.
  • Monitor neurologic status. Ifosfamide should be discontinued if severe CNS symptoms (agitation, confusion, hallucinations, unusual tiredness) occur. Symptoms usually abate within 3 days of discontinuation of ifosfamide but may persist for longer; fatalities have been reported.
  • Assess nausea, vomiting, and appetite. Weigh weekly. Premedication with an antiemetic may be used to minimize GI effects. Adjust diet as tolerated.
  • 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.
  • Lab Test Considerations: Monitor CBC, differential, and platelet count prior to and periodically during therapy. Withhold dose if WBC <2000/mm3 or platelet count is <50,000/mm3. Nadir of leukopenia and thrombocytopenia occurs within 7–14 days and usually recovers within 21 days of therapy.
    • Urinalysis should be evaluated before each dose. Withhold dose until recovery if urinalysis shows >10 RBCs per high-power field.
    • May cause ↑ in liver enzymes and serum bilirubin.
    • Monitor AST, ALT, serum alkaline phosphatase, bilirubin, and LDH prior to and periodically during therapy. Ifosfamide may cause ↑ in liver enzymes and serum bilirubin.
    • Monitor BUN, serum creatinine, phosphate, and potassium periodically during therapy. May cause hypokalemia.

Potential Nursing Diagnoses

Risk for infection (Side Effects)
Disturbed body image (Side Effects)

Implementation

  • Prepare solution in a biologic cabinet. Wear gloves, gown, and mask while handling IV medication. Discard IV equipment in specially designated containers.
  • Intravenous Administration
  • pH: 6.0.
  • Intravenous: Prepare solution by diluting each 1-g vial with 20 mL of sterile water or bacteriostatic water for injection containing parabens. Use solution prepared without bacteriostatic water within 6 hr. Solution prepared with bacteriostatic water is stable for 1 wk at 30°C or 6 wk at 5°C.
  • Intermittent Infusion: Diluent: May be further diluted in D5W, 0.9% NaCl, LR, or sterile water for injection.Concentration: 0.6 to 20 mg/mL (maximum 40 mg/mL). Dilute solution is stable for 7 days at room temperature or 6 wk if refrigerated.
  • Rate: Administer over at least 30 min.
  • Continuous Infusion: Has also been administered as a continuous infusion over 72 hr.
  • Y-Site Compatibility: acyclovir, alfentanil, allopurinol, amifostine, amikacin, aminocaproic acid, aminophylline, amiodarone, amphotericin B cholesteryl, amphotericin B colloidal, amphotericin B liposome, ampicillin, ampicillin/sulbactam, anidulafungin, atracurium, aztreonam, bivalirudin, bleomycin, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, carboplatin, caspofungin, cafazolin, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chlorpromazine, cimetidine, ciprofloxacin, cisatracurium, cisplatin, clindamycin, codeine, cyclosporine, cytarabine, dactinomycin, daptomycin, dexamethasone, dexmedetomidine, dexrazoxane, digoxin, diltiazem, dipehnhydramine, dobutamine, docetaxel, dolasetron, dopamine, doripenem, doxacurium, doxorubicin, doxorubicin liposome, doxycycline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, ertapenem, erythroycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, fluorouracil, foscarnet, fosphenytoin, furosemide, ganciclovir, gemcitabine, gentamicin, granisetron, haloperidol, heparin, hetastarch, hydrocortisone, hydromorphone, idarubicin, imipenem/cilastatin, insulin, isoproterenol, ketorolac, labetalol, leucovorin, levofloxacin, levorphanol, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, melphalan, meperidine, meropenem, mesna, methohexital, methylprednisolone, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitoxantrone, morphine, nalbuphine, naloxone, nesiritide, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxaliplatin, paclitaxel, palonosetron, pancuronium, pemetrexed, pentamidine, pentobarbital, phenobarbital, phenylephrine, piperacillin/tazobactam, potassium chloride, procainamide, prochlorperazine, promethazine, propofol, propranolol, quinupristin/dalfopristin, ranitidine, remifentanil, rocuronium, sargramostim, sodium acetate, sodium bicarbonate, sodium phosphates, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiopental, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, topotecan, trastuzumab, trimethoprim/sulfamethoxazole, vancomycin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine
  • Y-Site Incompatibility: cefepime, diazepam, methotrexate, pantoprazole, phenytoin, potassium phosphates
  • Additive Compatibility: carboplatin, cisplatin, epirubicin, etoposide, fluorouracil, mesna

Patient/Family Teaching

  • Emphasize need for adequate fluid intake throughout therapy. Patient should void frequently to decrease bladder irritation from metabolites excreted by the kidneys. Notify health care professional immediately if hematuria is noted.
  • Instruct patient to drink at least 8 glasses of water/day during and for 3 days after completion of therapy.
  • 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 urine, stool, or emesis; or confusion occurs.
  • Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Patients should also be cautioned not to drink alcoholic beverages or to take products containing aspirin or NSAIDs, as these may precipitate GI hemorrhage.
  • Review with patient the need for contraception during therapy.
  • Discuss with patient the possibility of hair loss. Explore methods of coping.
  • Advise patient to consult health care professional before taking any Rx, OTC, or herbal products.
  • Instruct patient not to receive any vaccinations without advice of health care professional; ifosfamide may decrease antibody response to and increase risk of adverse reactions from live-virus vaccines.

Evaluation/Desired Outcomes

  • Decrease in size or spread of malignant germ cell testicular carcinoma.
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