bleomycin

ROUTE	ONSET	PEAK	DURATION
IV, IM, SUBQ	2–3 wk	unknown	unknown

CV: hypotension, peripheral vasoconstriction

Derm: hyperpigmentation, mucocutaneous toxicity, alopecia, erythema, rash, urticaria, vesiculation

GI: anorexia, nausea, stomatitis, vomiting

Hemat: anemia, leukopenia, thrombocytopenia

Local: pain at tumor site, phlebitis at IV site

Metab: weight loss

Neuro: aggressive behavior, disorientation, weakness

Resp: pneumonitis, PULMONARY FIBROSIS

Misc: chills, fever, ANAPHYLACTOID REACTIONS

Interactions ⬆ ⬇

Drug-drug:

Hematologic toxicity ↑ with radiation therapy and other antineoplastics.
Cisplatin may ↑ risk of toxicity.
↑risk of pulmonary toxicity with other antineoplastics, thoracic radiation therapy, or general anesthesia.
↑risk of Raynaud phenomenon when used with vinblastine.

Route/Dosage ⬆ ⬇

Patients with lymphoma should receive initial test doses of ≤2 units for the first two doses.
IV IM SC (Adults and Children ): 0.25–0.5 unit/kg (10–20 units/m²) weekly or twice weekly initially. If favorable response, ↓ maintenance doses to 1 unit/day or 5 units/wk IM or IV. May also be given as continuous IV infusion at 0.25 unit/kg or 15 units/m²/day for 4–5 days.
Intrapleural(Adults ): 15–20 units instilled for 4 hr; then removed.

Availability ⬆ ⬇

(Generic available)

Powder for injection: 15 units/vial; 30 units/vial

Assessment ⬆ ⬇

Monitor vital signs before and frequently during therapy.
Assess for fever and chills. May occur 3–6 hr after administration and last for 4–12 hr.
Monitor for anaphylactic (fever, chills, hypotension, wheezing) and idiosyncratic (confusion, hypotension, fever, chills, wheezing) reactions. Keep resuscitation equipment and medications nearby. Patients with lymphoma are at particular risk for idiosyncratic reactions that may occur immediately or several hr after therapy, usually after the 1st or 2nd dose.
Assess for dyspnea and fine rales, the earliest sign and symptom of pulmonary toxicity. Monitor chest x-ray every 1–2 wk during therapy. If pulmonary changes occur, hold bleomycin to determine if causal. Consider monitoring pulmonary diffusion capacity (DL_co) at baseline and monthly during therapy. If DL_co<30–35% of baseline value, permanently discontinue bleomycin.
Assess nausea, vomiting, and appetite. Weigh weekly. Modify diet as tolerated. Antiemetics may be given before administration.

Lab Test Considerations:

Verify negative pregnancy status before starting therapy.
Monitor CBC before and periodically during therapy. May cause thrombocytopenia and leukopenia (nadir occurs in 12 days and usually returns to pretreatment levels by day 17).
- Monitor baseline and periodic renal and hepatic function.

Implementation ⬆ ⬇

High Alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order and dose calculations.
- Bleomycin should be administered in a monitored setting under the supervision of a physician experienced in cancer chemotherapy.
Prepare solution in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard equipment in specially designated containers.
- Patients with lymphoma should receive a 1- or 2-unit test dose 2–4 hr before initiation of therapy. Monitor closely for anaphylactic reaction. May not detect reactors.
- Premedication with acetaminophen, corticosteroids, and diphenhydramine may ↓ drug fever and risk of anaphylaxis.
IM: SC: Reconstitution: Inject 1–5 mL or 2–10 mL of sterile or bacteriostatic water for injection or 0.9% NaCl into 15 unit or 30 unit vials, respectively.

IV Administration:

Bleomycin is an irritant. If extravasation occurs, immediately stop infusion. Leave needle/cannula in place temporarily but do not flush the line. Gently aspirate extravasated solution; then remove needle/cannula. Elevate patient's extremity.
Intermittent Infusion: Reconstitution: Inject 5 mL or 10 mL of 0.9% NaCl into 15 unit or 30 unit vials, respectively. Reconstituted solution is stable for 24 hr at room temperature and for 14 days if refrigerated. Do not administer solution if discolored or contains particulates. Concentration: 3 units/mL.
Rate: Administer slowly over 10 min.
Y-Site Compatibility:
- acyclovir
- allopurinol
- amikacin
- aminocaproic acid
- aminophylline
- amiodarone
- ampicillin
- ampicillin/sulbactam
- anidulafungin
- argatroban
- atracurium
- azithromycin
- aztreonam
- bivalirudin
- bumetanide
- buprenorphine
- busulfan
- butorphanol
- calcium chloride
- calcium gluconate
- carboplatin
- carmustine
- caspofungin
- cefazolin
- cefepime
- cefotaxime
- cefotetan
- cefoxitin
- ceftazidime
- ceftriaxone
- cefuroxime
- chloramphenicol
- chlorpromazine
- ciprofloxacin
- cisatracurium
- cisplatin
- clindamycin
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- daptomycin
- daunorubicin
- dexamethasone
- dexmedetomidine
- dexrazoxane
- digoxin
- diltiazem
- diphenhydramine
- dobutamine
- docetaxel
- dopamine
- doxorubicin hydrochloride
- doxorubicin liposomal
- doxycycline
- droperidol
- enalaprilat
- ephedrine
- epinephrine
- epirubicin
- ertapenem
- erythromycin
- esmolol
- etoposide
- etoposide phosphate
- famotidine
- fentanyl
- filgrastim
- fluconazole
- fludarabine
- fluorouracil
- foscarnet
- fosphenytoin
- furosemide
- ganciclovir
- gemcitabine
- gentamicin
- glycopyrrolate
- granisetron
- haloperidol
- heparin
- hetastarch
- hydralazine
- hydrocortisone
- hydromorphone
- idarubicin
- ifosfamide
- imipenem/cilastatin
- insulin, regular
- irinotecan
- isoproterenol
- ketorolac
- labetalol
- leucovorin
- levofloxacin
- lidocaine
- linezolid
- lorazepam
- magnesium sulfate
- mannitol
- melphalan
- meperidine
- meropenem
- mesna
- methadone
- methohexital
- methotrexate
- methylprednisolone
- metoclopramide
- metoprolol
- metronidazole
- midazolam
- milrinone
- minocycline
- mitomycin
- mitoxantrone
- morphine
- moxifloxacin
- nafcillin
- nalbuphine
- naloxone
- nicardipine
- nitroglycerin
- nitroprusside
- norepinephrine
- octreotide
- ondansetron
- oxaliplatin
- paclitaxel
- palonosetron
- pamidronate
- pantoprazole
- pemetrexed
- pentamidine
- pentobarbital
- phenobarbital
- phentolamine
- phenylephrine
- piperacillin/tazobactam
- potassium acetate
- potassium chloride
- potassium phosphates
- procainamide
- prochlorperazine
- promethazine
- propranolol
- remifentanil
- rituximab
- rocuronium
- sargramostim
- sodium acetate
- sodium bicarbonate
- sodium phosphates
- succinylcholine
- sufentanil
- tacrolimus
- theophylline
- thiotepa
- tirofiban
- tobramycin
- topotecan
- trastuzumab
- trimethoprim/sulfamethoxazole
- vancomycin
- vasopressin
- vecuronium
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voriconazole
- zidovudine
- zoledronic acid
Y-Site Incompatibility:
- amphotericin B deoxycholate
- amphotericin B liposomal
- dantrolene
- diazepam
- phenytoin
- tigecycline
Intrapleural: Dissolve 60 units in 50–100 mL of 0.9% NaCl.
- Administer through thoracotomy tube. Position patient from supine to left and right lateral several times over the next 4 hr; then unclamp tube and re-establish suction as directed.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient to notify health care provider if fever, chills, wheezing, faintness, diaphoresis, shortness of breath, prolonged nausea and vomiting, anorexia, weight loss, or mouth sores occur.
Encourage patient not to smoke due to risk of worsen pulmonary toxicity.
Explain that skin toxicity may manifest itself as skin sensitivity, hyperpigmentation (especially at skin folds and points of skin irritation), and skin rashes and thickening.
Advise patient to notify health care provider prior to surgery so pulmonary toxicity prevention measures may be provided (FIO₂ at 25%, fluid replacement with colloid versus crystalloid).
Instruct patient to inspect oral mucosa for erythema and ulceration. If ulceration occurs, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Opioid analgesics may be required if pain interferes with eating.
Discuss with patient the possibility of hair loss. Explore coping strategies.
Instruct patient not to receive vaccinations without advice of health care provider.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to avoid pregnancy and use effective contraception during therapy. Advise patient to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased tumor size without evidence of hypersensitivity or pulmonary toxicity.

Code ⬆

NDC Code

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9240- Bleomycin
  - 0143-9240-01- 1 VIAL in 1 BOX, UNIT-DOSE (0143-9240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9241- Bleomycin
  - 0143-9241-01- 1 VIAL in 1 BOX, UNIT-DOSE (0143-9241-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

0409- Hospira, Inc.
- 0409-0323- Bleomycin
  - 0409-0323-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0323-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0332- Bleomycin
  - 0409-0332-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0332-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

16714- NorthStar Rx LLC
- 16714-886- Bleomycin
  - 16714-886-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-886-01) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

16714- NorthStar Rx LLC
- 16714-908- Bleomycin
  - 16714-908-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-908-01) / 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

53183- Sicor S.r.l.
- 53183-7003-
  - 53183-7003-1- 1 kg in 1 CARTON (53183-7003-1)

58623- Zhejiang Hisun Pharmaceutical Co., Ltd.
- 58623-0033-
  - 58623-0033-1- .5 kg in 1 DRUM (58623-0033-1)

58623- Zhejiang Hisun Pharmaceutical Co., Ltd.
- 58623-0033-
  - 58623-0033-2- 1 kg in 1 DRUM (58623-0033-2)

61703- Hospira, Inc.
- 61703-323- Bleomycin
  61703-323-22- 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-323-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

61703- Hospira, Inc.
- 61703-332- Bleomycin
  - 61703-332-18- 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-332-18) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-136- Bleomycin
  - 63323-136-10- 1 VIAL in 1 CARTON (63323-136-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-137- Bleomycin
  - 63323-137-20- 1 VIAL in 1 CARTON (63323-137-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

69097- Cipla USA Inc.
- 69097-364- Bleomycin
  - 69097-364-36- 1 VIAL in 1 CARTON (69097-364-36) / 1 INJECTION in 1 VIAL

71288- Meitheal Pharmaceuticals Inc.
- 71288-106- Bleomycin
  - 71288-106-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-106-10) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-107- Bleomycin
  - 71288-107-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-107-20) / 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

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Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

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Adv. Reactions/Side Effects ⬆ ⬇