Neupogen

Neupogen Adverse Reactions

filgrastim

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Clinical Trials: Summary of the safety profile: In clinical trials in cancer patients the most frequent undesirable effect was musculoskeletal pain which was mild or moderate in 10%, and severe in 3% of patients.
Graft versus Host Disease (GvHD) has also been reported (see Description of selected adverse reactions as follows).
In PBPC mobilisation in normal donors the most commonly reported undesirable effect was musculoskeletal pain. Leukocytosis was observed in donors and thrombocytopenia following filgrastim and leukapheresis was also observed in donors. Splenomegaly and splenic rupture were also reported. Some cases of splenic rupture were fatal.
In SCN patients the most frequent undesirable effects attributable to Neupogen were bone pain, general musculoskeletal pain and splenomegaly. Myelodysplastic syndromes (MDS) or leukaemia have developed in patients with congenital neutropenia treated with Neupogen (see Precautions).
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of granulocyte-colony stimulating factors; see Precautions and Description of selected adverse reactions as follows.
In clinical studies in patients with HIV, the only undesirable effects that were consistently considered to be related to Neupogen administration were musculoskeletal pain, bone pain and myalgia.
Tabulated summary of adverse reactions: Cancer patients: (See Table 2.)

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PBPC mobilisation in normal donors: (See Table 3.)

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SCN patients: (See Table 4.)

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Patients with HIV: (See Table 5.)

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Description of selected adverse reactions: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see Precautions).
Cases of capillary leak syndrome have been reported in the post-marketing setting with granulocyte-colony stimulating factor use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see Precautions).
Cancer patients: In randomised, placebo-controlled clinical trials, Neupogen did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy. In those clinical trials, undesirable effects reported with equal frequency in patients treated with Neupogen/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia (decreased appetite), mucosal inflammation, headache, cough, rash, chest pain, asthenia, pharyngolaryngeal pain (oropharyngeal pain) and constipation.
In the post-marketing setting cutaneous vasculitis has been reported in patients treated with Neupogen. The mechanism of vasculitis in patients receiving Neupogen is unknown. The frequency is estimated as uncommon from clinical trial data.
Cases of Sweets syndrome (acute febrile dermatosis) has been reported in the post-marketing setting. The frequency is estimated as uncommon from clinical trial data.
In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see Precautions).
Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim. Some cases of splenic rupture were fatal (see Precautions).
Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post marketing experience. Overall, reports were more common after IV administration. In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. Neupogen should be permanently discontinued in patients who experience a serious allergic reaction.
In the post-marketing setting, isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (see Precautions). The frequency is estimated as uncommon from clinical trial data.
Pseudogout has been reported in patients with cancer treated with Neupogen. The frequency is estimated as uncommon from clinical trial data.
PBPC mobilisation in normal donors: Common but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture have been reported in healthy donors and patients following administration of filgrastim. Some cases of splenic rupture were fatal (see Precautions).
Pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltration, dyspnoea and hypoxia) have been reported (see Precautions).
Exacerbation of arthritic symptoms has been uncommonly observed.
Leukocytosis (WBC > 50 x 109/l) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors (see Precautions).
In SCN patients: Undesirable effects seen include splenomegaly, which may be progressive in a minority of cases, splenic rupture and thrombocytopenia (see Precautions).
Undesirable effects possibly related to Neupogen therapy and typically occurring in < 2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis, and rash.
During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
In patients with HIV: Splenomegaly was reported to be related to Neupogen therapy in < 3% of patients. In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hyperplenism and no patients underwent splenectomy. As splenomegaly is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to Neupogen treatment is unclear (see Precautions).
Paediatric population: Data from clinical studies in paediatric patients indicate that the safety and efficacy of Neupogen are similar in both adults and children receiving cytotoxic chemotherapy suggesting no age-related differences in the pharmacokinetics of filgrastim. The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
There is insufficient data to further evaluate Neupogen use in paediatric subjects.
Other special populations: Geriatric use: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients. There is insufficient data to evaluate Neupogen use in geriatric subjects for other approved Neupogen indications.
Paediatric SCN patients: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with Neupogen. The frequency is estimated as 'common' from clinical trial data.
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. Healthcare professionals are asked to report any suspected adverse reactions as per local regulations.
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