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Fresenius Kabi
Further Expands Oncology Portfolio with Launch of
Cyclophosphamide
for Injection, USP
2024-02-28
·
BioSpace
上市批准
FDA-approved generic provides cost-effective option for treating
cancer
LAKE ZURICH, Ill.--(BUSINESS WIRE)--
Fresenius Kabi
announced today it has introduced
Cyclophosphamide
for Injection, USP, a generic substitute for
Cytoxan
, for use in treating several forms of
cancer
. Now available in the U.S.,
Cyclophosphamide
for Injection, USP is the newest addition to
Fresenius Kabi
’s broad portfolio of generic oncology injectables that help make
cancer
therapies more affordable and accessible. This press release features multimedia. View the full release here:
Cyclophosphamide
is now available from
Fresenius Kabi
. (Photo: Business Wire) “The introduction of
Cyclophosphamide
for Injection adds another critical treatment to our broad and leading oncology portfolio that offers lower-cost options for treating
cancer
,” said John Ducker, president and CEO of
Fresenius Kabi USA
. Supplied as a 500mg, 1g, and 2g single-dose vials of lyophilized powder, the drug can be administered intravenously or orally.
Fresenius Kabi
offers all lyophilized presentations of
cyclophosphamide
currently in the market.
Cyclophosphamide
for Injection, USP is available through distributors or direct from
Fresenius Kabi
. About
Cyclophosphamide
for Injection, USP
Cyclophosphamide
for Injection is an alkylating drug indicated for the treatment of: Malignant Diseases:
malignant lymphomas
:
Hodgkin's disease
,
lymphocytic lymphoma
,
mixed-cell type lymphoma
,
histiocytic lymphoma
,
Burkitt's lymphoma
;
multiple myeloma
,
leukemias
,
mycosis fungoides
,
neuroblastoma
,
adenocarcinoma of ovary
,
retinoblastoma
,
breast carcinoma
Minimal Change Nephrotic Syndrome
in Pediatric Patients: biopsy proven
minimal change nephrotic syndrome
patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. IMPORTANT SAFETY INFORMATION
Cyclophosphamide
for Injection is contraindicated in patients with
hypersensitivity
to
cyclophosphamide
and with
urinary outflow obstruction
.
Myelosuppression
, Immunosuppression,
Bone Marrow Failure
and
Infections
- Severe immunosuppression may lead to serious and sometimes fatal
infections
. Close hematological monitoring is required. Urinary Tract and Renal Toxicity -
Hemorrhagic cystitis
,
pyelitis
, ureteritis, and
hematuria
can occur. Exclude or correct any
urinary tract obstructions
prior to treatment. Cardiotoxicity -
Myocarditis
,
myopericarditis
,
pericardial effusion
,
arrhythmias
and
congestive heart failure
, which may be fatal, have been reported. Monitor patients, especially those with risk factors for
cardiotoxicity
or pre-existing
cardiac disease
.
Pulmonary Toxicity - Pneumonitis
,
pulmonary fibrosis
and
pulmonary veno-occlusive disease
leading to
respiratory failure
may occur. Monitor patients for signs and symptoms of pulmonary toxicity.
Secondary malignancies
have been reported in patients treated with
cyclophosphamide
-containing regimens.
Veno-occlusive Liver Disease
- Fatal outcome can occur. Embryo-Fetal Toxicity - Can cause fetal harm. Advise female patients of reproductive potential to avoid pregnancy. Adverse reactions reported most often include
neutropenia
,
febrile neutropenia
,
fever
,
alopecia
,
nausea
,
vomiting
, and
diarrhea
. To report SUSPECTED ADVERSE REACTIONS, contact
Fresenius Kabi USA, LLC
at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . Nursing Mothers: Discontinue drug or nursing. Females and males of reproductive potential: Counsel patients on pregnancy prevention and planning. Renal Patients: Monitor for toxicity in patients with moderate and severe
renal impairment
. This Important Safety Information does not include all the information needed to use
Cyclophosphamide
for Injection, USP safely and effectively. Please see the full prescribing information for
Cyclophosphamide
for Injection, USP at . About
Fresenius Kabi
Fresenius Kabi
( ) is a global health care company that specializes in injectable medicines, biosimilars, clinical nutrition and technologies for infusion and transfusion. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at
Fresenius Kabi
, visit us at and follow us on LinkedIn and Facebook.
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机构
Fresenius Kabi Oncology Ltd.
Fresenius Kabi USA LLC
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