A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Targretin Indications, Dosage, Storage, Stability - Bexarotene
Targretin Indications, Dosage, Storage, Stability - Bexarotene
INDICATIONS
Targretin ® (bexarotene) capsules are indicated for the treatment of
cutaneous manifestations of cutaneous T-cell lymphoma in patients who
are refractory to at least one prior systemic therapy.
DOSAGE AND ADMINISTRATION
The recommended initial dose of Targretin ® capsules is 300 mg/m ²/day.
(See Table 4.) Targretin ® capsules should be taken as a single oral daily
dose with a meal. See CONTRAINDICATIONS
:
Pregnancy Category X section for precautions to prevent pregnancy
and birth defects in women of child-bearing potential.
Table 4. Targretin ® Capsule Initial Dose Calculation
According to Body Surface Area
|
Initial Dose Level (300 mg/m2/day)
|
Number of 75 mg Targretin Capsules
|
|
Body Surface Area (m2)
|
Total Daily Dose (mg/day)
|
|
0.88 - 1.12
|
300
|
4
|
|
1.13 - 1.37
|
375
|
5
|
|
1.38 - 1.62
|
450
|
6
|
|
1.63 - 1.87
|
525
|
7
|
|
1.88 - 2.12
|
600
|
8
|
|
2.13 - 2.37
|
675
|
9
|
|
2.38 - 2.62
|
750
|
10
|
Dose Modification Guidelines: The 300 mg/m²/day dose level of Targretin
® capsules may be adjusted to 200 mg/m²/day then to 100 mg/m²/day,
or temporarily suspended, if necessitated by toxicity. When toxicity is
controlled, doses may be carefully readjusted upward. If there is no tumor
response after eight weeks of treatment and if the initial dose of 300
mg/m²/day is well tolerated, the dose may be escalated to 400 mg/m²/day
with careful monitoring.
Duration of Therapy: In clinical trials in CTCL, Targretin ® capsules
were administered for up to 97 weeks.
Targretin ® capsules should be continued as long as the patient is deriving
benefit.
HOW SUPPLIED
Targretin ® capsules are supplied as 75-mg off-white, oblong soft gelatin
capsules, imprinted with "Targretin," in high density polyethylene bottles
with child-resistant closures.
Bottles of 100 capsules...................................... NDC 64365-502-01
Store at 2° -25 ° C (36 ° -77 ° F). Avoid exposing to
high temperatures and humidity after the bottle is opened. Protect from
light.
top
