Doxil package insert draft 5 alza confidential date revised. Highlights of prescribing information platinumresistant. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Accidental substitution of doxil for doxorubicin hcl has resulted in severe side effects. Withhold doxil for grade 1, 2, or 3 infusionrelated reactions and resume at a reduced infusion rate. Xgeva includes the same active ingredient denosumab found in prolia. Liposomal doxorubicinassociated acute hypersensitivity despite. The use of doxil doxorubicin hcl liposome injection. Doxil warnings and precautions because doxil can decrease the bone marrows ability to produce blood cells, anemia and other serious conditions can occur in people using it. The patient package insert and oral dispenser should be. Mozobil plerixafor injection, for subcutaneous use. Doxorubicin is an anthracycline topoisomerase inhibitor isolated from streptomyces peucetius var.
This solution is readytouse and may be administered directly to the patient without further preparation. Caelyx consists of a liposomal formulation of doxorubicin hcl encapsulated in a delivery system of long circulating liposomes. Prevention of infusion reactions to pegylated liposomal. Doxorubicin hydrochloride injectionfor injection is an anthracycline topoisomerase inhibitor indicated. Caelyx pegylated liposomal, inndoxorubicin hydrochloride. Doxil is provided as a sterile, translucent, red liposomal dispersion in 10ml or 30ml glass, single use vials. You are encouraged to report negative side effects of medical devices or prescription drugs to the fda. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery.
To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Care in the administration of doxorubicin will reduce the chance of perivenous infiltration see package insert. Dermatologic toxicity in a patient receiving liposomal. Doxorubicin may potentiate the toxicity of other anticancer therapies see package insert for precautions, drug interactions. Doxil should not be substituted for doxorubicin hcl on a mg per mg basis see dosage and administration 2. Aug 01, 2019 doxil displayed linear pharmacokinetics over the range of 10 to 20 mgm 2. The molecular formula of the drug is c27 h29 no11hcl. The mechanism of action of doxorubicin hcl is thought to be related to its ability to bind dna and inhibit nucleic acid synthesis. Relative to doxil doses at or below 20 mgm 2, the pharmacokinetics of total doxorubicin following a 50 mgm 2 doxil dose are nonlinear. Each singledose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mgml equivalent to 1. Each vial also contains anhydrous citric acid and mannitol. Doxorubicin liposomal fda prescribing information, side. Doxorubicin hydrochloride for injection, usp adriamycin. For the first cycle the infusion rate varies for each patient it is slowly ramped up.
Insert tip firmly into opening of the bottle adapter. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Serious irreversible myocardial toxicity with delayed congestive. Doxorubicin hydrochloride for injection, usp for intravenous use only rx only warnings 1. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Adriamycin must not be given by the intramuscular or subcutaneous route. Aug 16, 2019 initiate doxil infusions at a rate of 1 mgmin and increase rate as tolerated see dosage and administration 2. See 17 for patient counseling information and fdaapproved patient labeling.
Product information adriamycin solution for injection warnings 1. Sep 10, 2019 doxil package insert pdf doxil doxorubicin hcl liposome injection is indicated for certain types of the time the drug is in the body. The clinical formulation is supplied in a sterile form for intravenous use only. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Mar 22, 2020 doxil package insert pdf doxil doxorubicin hcl liposome injection is indicated for certain types of the time the drug is in the body. With the first doxil dose, an initial rate of 1 mgmin should be used to minimize the risk of infusionrelated reactions. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and 3.
Nov 01, 2019 doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. Extravasation of the drug into surrounding tissue may cause severe pain, tissue damage and cellulitis. Dailymed dacarbazine injection, powder, for solution. This part of the emedtv web site gives a complete overview of this medication, with information on how it is given, potential side effects, and more. Doxil package insert pdf doxil doxorubicin hcl liposome injection is indicated for certain types of the time the drug is in the body. Abraxane is indicated for the firstline treatment of locally advanced or metastatic nonsmall cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10 ml or 25 ml glass, single dose vials. Doxorubicin, an anthracycline antibiotic, damages dna by intercalation into dna, metal ion chelation. Doxil package insert draft 4 alza confidential date revised. Doxil 30 mgm2 should be administered as a 1hr intravenous infusion on day 4 following bortezomib. It also has been used with limited success in a clinical trial of previously treated patients with endometrial cancer. Cyclophosphamide for injection, usp rx only description cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Caelyx, inndoxorubicin hydrochloride european medicines agency. May 26, 2019 doxil package insert pdf doxil doxorubicin hcl liposome injection is indicated for certain types of the time the drug is in the body. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Aidsinfo provides the following drug label solely as an example of the labels available for symfi. The most common adverse reactions include asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea.
Other warnings and precautions with doxil apply to people with heart problems, women who are pregnant, and people with liver disease. Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out. Afinitor is not for use in people with carcinoid tumors that actively produce hormones. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. At this dose, the elimination halflife of doxil is longer and the clearance lower compared to a 20 mgm 2 dose. Page 1 of 14 highlights of prescribing information these highlights do not include all the information needed to use libtayo safely and effectively.
Frequently asked questions temporary importation of. Bystolic may be used alone or in combination with other antihypertensive agents see drug interactions 7. It is a cardioprotective agent for use in conjunction with doxorubicin. Actemra subcutaneous formulation is not intended for. Doxil package insert draft 2 alza confidential date revised. Highlights of prescribing information these highlights do not include all the information needed to use blincyto safely and effectively.
Store unreconstituted vial at controlled room temperature, 20 to 25c 68 to 77f. Doxorubicin liposomal dosage and administration important use information. The pegylated liposome carriers are composed of cholesterol. Pegylated liposomal doxorubicin pld is a formulation of doxorubicin in polyethylene glycol peg coated stealth liposomes. Caelyx pegylated liposomal, a liposome formulation, is doxorubicin hydrochloride. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive.
Dacogen decitabine forinjection, for intravenous use initial u. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride, usp at a concentration of 2 mgml and a ph of 6. Tamiflu oseltamivir phosphate capsules and for oral. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. The stealth liposome carriers are composed of n carbonyl methoxypolyethylene glycol 20001,2distearoyl sn glycero3phosphoethanolamine sodium salt mpegdspe, 3. Idamycin idarubicin hydrochloride for injection, usp. Doxil warnings and precautions ovarian cancer home page. Severe local tissue necrosis will occur if there is extravasation during administration. Doxil in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. Tamiflu oseltamivir phosphate capsules and oral solution.
Doxil doxorubicin hydrochloride liposome injection, for intravenous use. Doxorubicin liposomal doxil, lipodox prior auth criteria proprietary information. It is supplied in the hydrochloride form as a sterile redorange lyophilized powder containing lactose and as a sterile parenteral, isotonic solution with sodium chloride for intravenous use only. Each ml of the sterile solution contains 20 mg of plerixafor. Highlights of prescribing information these highlights do not. Liposomal doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for ovarian cancer, aidsrelated kaposi sarcoma, and multiple myeloma. Doxil package insert draft daksil doxorubicin hcl liposome. Doxil fda prescribing information, side effects and uses. Clinimix sulfitefree amino acid in dextrose injections in clarity dual. You deserve to have your pain controlled so you can enjoy life.
Highlights of prescribing information these highlights do not include all the information needed to use reclast safely and effectively. Highlights of prescribing information hypocalcemia may worsen. Each 10 mg lyophilized vial contains 10 mg of doxorubicin hydrochloride, usp and 50 mg of lactose monohydrate, nf. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Literature reports suggest that adding cyclosporine to doxorubicin results in more profound and prolonged hematologic toxicity than that observed. Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose.
Doxorubicin hydrochloride liposome injection is contraindicated in patients who have a historyofsevere hypersensitivityreactions, including anaphylaxis, to doxorubicin hcl see warnings and precautions 5. Highlights of prescribing information these highlights do not include all the information needed to use femara safely and effectively. Erbitux can cause serious and fatal infusion reactions. Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with granulocytecolony stimulating factor gcsf to mobilize hematopoietic stem cells hscs to the peripheral blood for collection and subsequent autologous transplantation in patients with nonhodgkins lymphoma and multiple myeloma. Highlights of prescribing information adequately rehydrate. The stealth liposome carriers are composed of cholesterol. As a prescription chemotherapy drug, doxil is used to treat ovarian and other types of cancer. The100 ml vial size is a hospital pharmacy bulk pack intended for multi dose dispensing.
Several fdaapproved drug labels may be available for symfi. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Discontinue doxil for serious or lifethreatening infusionrelated reactions. Phase ii evaluation of liposomal doxorubicin doxil in recurrent or advanced leiomyosarcoma of the uterus. Highlights of prescribing information palmarplantar.
Dailymed doxil doxorubicin hydrochloride injection. Doxil 30 mgm 2 should be administered as a 1hr intravenous infusion on day 4 following bortezomib. No formal drug interaction studies have been conducted with doxil. Restricted access do not disseminate or copy without approval. Highlights of prescribing information these highlights do not include all the information needed to use dacogensafely and effectively. Doxil has more time to reach the tumor hipno tera pija menu. Ive thought to myself that i would take a couple of doxil s if i got to the end and pain was a problem. Prevention of infusion reactions to pegylated liposomal doxorubicin via tachyphylaxis induction by placebo vesicles. Aug 24, 2019 doxil package insert pdf doxil doxorubicin hcl liposome injection is indicated for certain types of the time the drug is in the body. Injection of concentrated dacarbazine solutions may cause severe pain along the vein. Highlights of prescribing information these highlights do not include all the information needed to use doxil safely and effectively.
1014 554 1231 1061 817 915 1272 179 864 1131 157 1190 367 92 345 588 418 132 1053 1427 794 975 1303 1280 1071 1195 963 1486 383