Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Like most cytostatic agents, bleomycin can produce immediate and delayed toxic effects. The earliest reaction is fever on the day of the injection. Loss of appetite, fatigue and nausea may also occur. Pain at the injection site and in the region of the tumor has occasionally been observed.
Other sporadic side effects include hypotension and local thrombophlebitis after intravenous injection.

Skin and mucosal changes, observed in up to 50% of treated patients, are the most common side effects. These manifest as erythema, pruritus, exanthema, striae, ulcerations, blistering, hyperpigmentation, and tenderness and swelling of the fingertips.

Bone marrow
Bleomycin does not appear to cause significant bone marrow depression. Thrombocytopenia associated with bleomycin has been attributed to increased platelet consumption rather than to decreased platelet formation.

In addition, Raynaud's phenomenon has been reported in association with bleomycin used as monotherapy and as part of combination therapy.

The following undesirable effects may occur during treatment with bleomycin: 
Frequencies are defined as follows:
Very common (>1/10), common (≥1/100, <1/10), uncommon (≥1/1 000, <1/100), rare (≥1/10 000, <1/1 000), very rare (<1/10 000).

Primary system     Very common           Common           Uncommon           Rare           Very organ class        >1/10                 ≥1/100–          ≥1/1 000–          ≥1/10 000–     rare <1/10            <1/100             <1/1 000       <1/10 000
Primary system       Very common    Common              Uncommon           Rare                  Very organ class          >1/10          ≥1/100–             ≥1/1 000–          ≥1/10 000–            rare <1/10               <1/100             <1/1 000              <1/10 000 Blood and                                               Myelosuppression Febrile lymphatic system                                        Leukopenia       neutropenia disorders                                               Neutropenia
Thrombocytopenia
Bleeding
Immune system                       Idiosyncratic       Anaphylaxis disorders                           reactions           Anaphylactoid reaction
Hypersensitivity
Nervous system                      Headache            Dizziness disorders                                               Confusion
Cardiac disorders                                                          Pericarditis Chest pain
Vascular disorders                                      Hypotension        Myocardial infarction*
Stroke
Thrombotic microangiopathy
Hemolytic uremic syndrome
Cerebral vasculitis
Raynaud's disease
Arterial thrombosis
Deep vein thrombosis
Respiratory,         Interstitial   Pulmonary thoracic and         lung disease   fibrosis* mediastinal          Dyspnea        Acute respiratory disorders                           distress syndrome
(ARDS)
Respiratory failure
Pulmonary embolism
Gastrointestinal                    Anorexia            Angular disorders                           Weight-             stomatitis loss                Diarrhea
Nausea
Vomiting
Mucositis
Stomatitis
Hepatobiliary                                                              Hepatic disorders                                                                  impairment Hepatitis
Primary system       Very common         Common           Uncommon            Rare          Very organ class          >1/10               ≥1/100–          ≥1/1 000–           ≥1/10 000–    rare <1/10            <1/100              <1/1 000      <1/10 000
Skin and             Erythema            Exanthema        Deformation and     Scleroderma subcutaneous         Pruritus            Urticaria        discoloration of tissue disorders     Striae              Erythema         the nails
Blistering          Induration       Blister formation
Hyperpigmentation   Edema            over
Tenderness          Hyperkeratosis   pressure points and                 Alopecia swelling            Dermatitis of the fingertips
Musculoskeletal,                                          Muscle and connective tissue                                         limb pain and bone disorders
Renal and urinary                                         Oliguria disorders                                                 Painful urination
Polyuria
Urinary retention
General                                  Fever            Pain in the                       Tumor disorders and                            Chills           tumor area                        lysis administration                           Malaise          Phlebitis                         syndrome site conditions                                           Vein wall hypertrophy and venous access stenosis
(with IV administration)
Induration (with
IM or topical administration)
*with a fatal outcome

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/