6

mg/m^2

Intravenous (IV)

with other anti-cancer agents

0.3 - 0.4

mg/kg

Intravenous (IV)

one time only

1 - 4

weeks

adjuvant treatment: 175 mg/m2 IV over 3hrs 3 weeks for four courses administered sequentially to doxorubicin containing chemotherapy :

175

mg

Intravenous (IV)

over 3 hr

3

weeks

Initial dose:

3.7

mg/m^2

Intravenous (IV)

usual dose: 5.5-7.4 mg per m2 IV once every 7 days <>br Max: 18.5 mg per m2 once every seven days.
The patient should not take a high dose if the white cell count reduces to 3000 cells per mm3.

Single drug-treatment:

60 - 75

mg/m^2

Intravenous (IV)

over 3 to 10 minutes once in 21 days for 4 cycles.
Combination drug-treatment: 30 to 60 mg/m2 IV once every 21 to 28 days in combination with cyclophosphamide, fluorouracil, and docetaxel.

10

mg

Orally

once a day

the total duration of therapy is continued until disease progression or no toxicity occurs
Note:
Do not combine the brands of Afinitor tablets and Afinitor Disperz to reach the desired dose
Only use any one of them

For postmenopausal patients:

1

mg

Orally 

once a day

until tumor progression

300

mg

Orally

once a day

;Treatment continued until the disease progression, or unacceptable toxicity occurs
The dose recommended for fulvestrant is 500 mg given orally on days 1, 15, and 29, and once monthly thereafter
Note:
Alpelisib with fulvestrant combination used for the treatment of PIK3CAmutated, postmenopausal women, and men, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer and recommended by FDA

5 years of duration of therapy for postmenopausal females:

60

mg

Orally 

once a day

The duration can be modified for use longer than 5 years depending on the disease progression and symptoms
Limitations of raloxifene therapy:
No specific recommendation is available for the effectiveness of raloxifene in breast cancer associated with BRCA1 and BRCA2
Not indicated for the reduction of the risk of recurrence of breast cancer
Not recommended for reduction in risk of non-invasive breast cancer

Dose Adjustments

Use with caution if creatinine clearance is <50 ml/minute
No significant data available for dose adjustment for hepatic impairment

150

mg

Orally

twice a day

; when used with tamoxifen or an aromatase inhibitor
The treatment needs to be continued for two years until the disease progression or unacceptable toxicity occurs

840

mg

Intravenous (IV)

was given on days 1 and 15, followed by protein-bound paclitaxel and 100 mg per m2 IV on Days 1, 8, and 15 for each 28-day course cycle
Continue the course until disease progression, or unacceptable toxicity occurs
Note:
the first infusion administered for over 60 minutes if well-tolerated, and subsequent infusions administered for around 30 minutes

First-line adjuvant therapy:

25

mg

Orally 

once a day

for 5 years
Postmenopausal patients: 25 mg orally once a day for 5 years of endocrine therapy, following 2 to 3 years of tamoxifen therapy

Advanced Breast cancer:
25 mg orally once a day in combination with everolimus
Risk reduction treatment for Breast cancer:
Premenopausal for women > 35 years: 25 mg orally once a day for 5 years

Dose Adjustments

Decreased mineral density of bone: manage bone density with suitable supplements as clinically indicated
Vitamine D deficiency: administer the supplement as clinically indicated

1

mg

Capsule

Orally 

once a day

Continue the therapy until disease progression or unacceptable toxicity occurs 

Dose Adjustments

Renal Dose Adjustments:  Mild: No adjustment recommended  Moderate (CrCl 30-59 ml/min): 0.75 mg orally once a day  Severe (CrCl 15-29 ml/min): 0.5 mg orally once a day  Liver Dose Adjustments:  No adjustment recommended 

3.6

mg

Subcutaneous (SC)

28

days

which is placed in the upper abdominal wall
Long term treatment intended for unless clinically inappropriate

Initial dose: 4 mg/kg IV over 90 mins
Maintenance dose: 2 mg/kg IV over 30 min every 3 Weeks during the first 12 weeks of chemotherapy, 6 mg/kg IV infused over 30 to 90 minutes every 3 Weeks for 52 weeks 1 week after chemotherapy completed
Adjuvant treatment with concurrent docetaxel/carboplatin:
Initial dose: 4 mg/kg IV over 90 mins
Maintenance dose: 2 mg/kg IV over 30 min every Week during the first 18 weeks of chemotherapy, 6 mg/kg IV infused over 30 to 90 minutes q3Weeks for 52 weeks 1 week after chemotherapy completed
Adjuvant treatment with anthracycline-based chemotherapy:
Initial dose: 8 mg/kg IV over 90 mins
Maintenance dose: 6 mg/kg IV infused over 30 to 90 minutes every 3 Weeks for 52 weeks 1 week after chemotherapy completed

500 or 600 mg/m² intravenously on 1st and 8th day of every 28 days cycle for 6 cycles, as a part of multi drug regimen, based on cyclophosphamide

Indicated combined with paclitaxel for 1st line treatment of metastatic breast cancer that occurs after the anthracycline-containing adjuvant chemotherapy failure 1250 mg/m² intravenously for 30 minutes on 1st and 8th day of every 21-days cycle It can also be given with 175 mg/m² paclitaxel on 1st day as a 3 hourly infusion prior to gemcitabine

Metastatic Breast Cancer i.e., HER2-overexpressing
1250 mg per day should be given orally from 1st to 21st day along with capecitabine on 1st to 14th day, repeatedly in a 21-day cycle
HER2-positive advanced breast cancer:
1500 mg orally each day in combination with 2.5 mg lapatinib orally each day
Dose modifications:
Diarrhea
In case of Grade 3 diarrhea interrupt the dosing
Other toxicities
In case of Grade 2 or more toxicity interrupt the dosing

Early-stage breast cancer
In the adults diagnosed with early-stage breast cancer, 240 mg of the drug in the form of tablets is administered orally each day for one year

ribociclib is indicated in women with (HR)-positive hormone receptor (HER2) human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
A dose of 600 mg is administered each day orally for the initial 21 days of every 28-day cycle
The medication is continued until the disease is reduced to acceptable toxicity

Dose Adjustments

In case of adverse reactions, the dose is modified or reduced
The pattern of dose reduction goes like this
First dose reduction: 400 mg daily
Second dose reduction: 200 mg daily
In case the patient is unable to tolerate 200 mg daily, discontinue the treatment
Hepatic impairment
In the case of mild Child-Pugh A, there is no dose adjustment required
In case of moderate-to-severe Child-Pugh B or C: Reduce the starting dose to 400 mg/day
Renal impairment In the case of mild-to-moderate (CrCl ≥30 mL/min): No dose adjustment is necessary
In case of severe (CrCl 15-30 mL/min): reduce the starting dose to 200 mg/day

palbociclib is indicated in patients for the treatment of patients with breast cancer
Patients with positive hormone receptors and negative human epidermal growth factor receptors 2 are treated with palbociclib
palbociclib and aromatase inhibitor in combination are administered in post-menopausal women and men with breast cancer
Combination therapy
125 mg tablet in combination with an aromatase inhibitor or fulvestrant is given orally, four times daily from the 1st to the 21st day, in a 28-day cycle
In case of adverse reactions, the dose is modified or reduced
The pattern of dose reduction goes like this
First dose reduction: 100 mg/day
Second dose reduction: 75 mg/day
In case of more reduction of dose, discontinue the treatment

Dose Adjustments

In case of adverse reactions
1st dose reduction- reduce the dose to 100 mg per day
2nd dose reduction- reduce the dose to 75 mg per day
Discontinue the treatment if further dose reduction is required
In case of hepatic impairment
Mild or moderate hepatic impairment, no dose adjustment required
Severe hepatic impairment required a reduced dose to 75 mg/day for the initial 21 days of each 28-day cycle
Renal impairment
No dose adjustment is required in case of mild to moderate to severe renal impairment (CrCl >15 mL/min)
No studies have been performed in the case of hemodialysis

recommended in conjunction with chemotherapy for patients with metastatic HER2-positive (HER2+) breast cancer who have had two or more anti-HER2 regimens, at least one for treating metastatic disease.
every three weeks, 15 mg/kg intravenous
Continue until the condition worsens or the toxicity becomes intolerable

Dose Adjustments

Dosage Modifications
Dysfunction of left ventricle
Delay dosage for about four weeks.
Left ventricular ejection fraction (LVEF) decreased by 16% in absolute terms from baseline.
LVEF below normal institutional limits (or 50% if there are no restrictions) and a 10% absolute decline from pretreatment values in LVEF
LVEF must rebound to normal ranges, and the absolute drop from baseline must be 15% within eight weeks before treatment may continue.
Immediately stop using
LVEF decrease lasts longer than eight weeks, or Dosing stopped more than three times due to LVEF deterioration
Reactions associated with infusion
Reduce infusion rate if it's mild or moderate

Indicated for Fibrocystic Breast Cancer
100-400 mg/day orally divided twice daily
The therapy is maintained for 3-6 months
In approximately half of the patients, the symptoms will reoccur within 1 year
Hence restart the treatment if required

It is indicated for management of metastatic breast cancer in females
50-100 mg intramuscularly as a deep injection, once every week

testosterone enanthate is indicated for non-surgical breast cancer in women
200-400 mg intramuscularly every 2-4 weeks

It is used as an adjunctive therapy in the treatment of disseminated or advanced breast carcinoma. The condition prevails in women after menopause, who are given hormonal therapy and whose ovarian function is terminated subsequently
250 mg orally every 6 hours for at least 3 months

Indicated for reducing the pain and symptoms due to advanced breast carcinoma
40 mg orally every 6 hours daily for 2 months
It shouldn’t be used as a substitute of radiotherapy, chemotherapy, or surgery

40

mg/m²

Intravenous (IV)

over 3 hr

3

week

Do not exceed 88 mg daily

Triple negative breast carcinoma

10 mg/kg intravenously on the 1st and 8th day of 21 days cycle

HR-positive, HER2-negative breast carcinoma
10 mg/kg intravenously on the 1st and 8th day of 21 days cycle

Indicated for locally advanced/metastatic breast cancer that HER2-positive unresectable
The drug is pending FDA approval

Indicated as combined with paclitaxel for 1st line treatment for HER2-overexpressing metastatic breast cancer
600 mg trastuzumab with 1000 units of hyaluronidase subcutaneously every 3 weeks
It can be used singly or as a combination with docetaxel & carboplatin
or
in combination with cyclophosphamide, doxorubicin, and docetaxel/paclitaxel
Continue until the disease is progressed

Indicated for breast cancer:

Early breast cancer
Indicated as adjuvant therapy of positive for HER2 early breast cancer (EBC) patients with remaining invasive disease following taxane and trastuzumab-based treatment
3.6mg/kg intravenously every 3 weeks
Dosages more than 3.6 mg/kg should not be given.
Unless disease progression or intolerable toxicity occurs, therapy should be continued for 14 cycles.

Metastatic breast cancer
Indicated for the treatment of metastatic breast cancer (MBC) and HER2-positive, in patients who have received trastuzumab and a taxane, separately or in combination
3.6mg/kg intravenously every 3 weeks
Dosages more than 3.6 mg/kg should not be given.
Continue until illness recurrence or intolerable toxicity.

Dose Adjustments

Adverse reactions for dosage reduction
First dosage reduction: 3 mg/kg
Second dosage reduction: 2.4 mg/kg
Need for additional dosage reduction: Treatment should be discontinued.
Hepatotoxicity
MBC
AST/ALT >2.5 to ≤5x ULN in Grade 2: keep the dosage level constant
AST/ALT >5 to ≤20x ULN in Grade 3: Delay administration until AST/ALT returns to Grade ≤2, then lower one dosage level.
Grade 4 (AST/ALT >20x ULN): Immediately stop using

EBC
Grade 2 (AST >3 to ≤5x ULN on the treatment day): Delay administration until AST recovers to Grade ≤1, then continue at the same dosage level.
Grade 2 or 3 (ALT >3 to ≤20x ULN) or Grade 3 (AST >5 to ≤20x ULN) on treatment day: When ALT/AST returns to Grade ≤1, wait and lower the dosage by one level.
AST/ALT >20x ULN at any moment in grade 4: Immediately stop using
Hyperbilirubinemia
MBC
Total bilirubin >1.5 to ≤ 10x ULN in Grade 2: Only provide when total bilirubin returns to ≤Grade 1, then maintain the same dosage level.
Total bilirubin >3 to ≤10x ULN in grade 3: Reduce 1 dosage level after waiting for total bilirubin to return to Grade ≤1 before administering.
Total bilirubin >10x ULN in grade 4: Immediately stop using

EBC
Total bilirubin >1 to ≤2x ULN on the day of treatment: Reduce 1 dosage level after delaying administration until total bilirubin is less than ≤1x ULN.
At any moment, total bilirubin >2x ULN: Immediately stop using
Left ventricular dysfunction
MBC
LVEF <40%: Do not provide medication; re-evaluate LVEF after 3 weeks; if LVEF <40% is verified, stop medication
LVEF 40% to ≤45% and a ≥10% point decline from baseline. Do not provide the medication; reassess the LVEF after three weeks; if the LVEF has not improved to within 10% of baseline, stop the medication.
LVEF 40% to ≤45% and a <10% point decline from baseline. Maintain drug use and LVEF testing within three weeks.
LVEF >45%: maintain drug

EBC
LVEF <45%: Do not provide medicine; repeat LVEF evaluation after 3 weeks, if <45% confirmed, cease treatment
LVEF 45% to <50% and reduction is ≥10% points from baseline: Do not provide medicine; repeat LVEF evaluation after 3 weeks; If LVEF stays below 50% and hasn't improved by at least 10% from baseline, treatment should be stopped.
LVEF 45% to <50% and reduction is <10% from baseline: Continue medication and reassess LVEF within 3 weeks
LVEF >50%: Keep treating

Heart failure
MBC
Symptomatic heart failure: Stop the treatment
EBC
Symptomatic CHF, Grade 3-4 LVSD or Heart Failure, or Grade 2 Heart Failure with LVEF<45%: Stop using the medication.
Thrombocytopenia
MBC
Grade 3 (platelets 25,000/mm3 to ≤50,000/mm3): Do not provide until the platelet count returns to Grade ≤1 (e.g.,≥75,000/mm3), and then continue at the same dosage level.
Platelets <25,000/mm3 (Grade 4): Do not give until the platelet count has returned to Grade ≤1 (e.g., ≥75,000/mm3), and then lower the dosage by one level.
EBC Grade 3 (platelets 25,000/mm3 to ≤75,000/mm3 on treatment day): Do not give until the platelet count returns to Grade ≤1 (i.e., ≥75,000/mm3), and then continue at the same dosage level; if the patient needs two delays, consider lowering the dose by one level. Grade 4 (Platelets <25,000/mm3): Do not give until the platelet count has returned to Grade ≤1 (e.g., ≥75,000/mm3), and then lower the dosage by one level. Pulmonary toxicity Pneumonitis or interstitial lung disease: discontinue it permanently Pneumonitis brought on by radiotherapy (EBC alone) Grade 2: Stop if the condition does not improve with usual care. Grade 3-4: Treatment should be discontinued Renal impairment Mild-to-moderate: No dosage change is required (CrCl ≥30 mL/min) Severe (CrCl<30 mL/min): No dose change can be suggested for cases due to the lack of information. Hepatic impairment Mild to moderate: No dosage modification is necessary; patients with hepatic impairment should be continuously monitored due to the possibility of medication-associated hepatotoxicity. Severe: Unstudied

Indicated for Breast cancer, early, adjuvant therapy as off-label
For Postmenopausal individuals:
1600 mg orally one time a day for 2-3 years
Hypercalcemia of malignancy
Initial dose: 300 mg intravenously for nearly 2 hr one time a day. Continue till the calcium level reaches normal (i.e., 2-5 days)
The therapy period should not exceed seven days
Maintenance dose: After calcium level reaches to normal, use intravenous bisphosphonate treatment
Oral dose: 1.6 gm-2.4 gm every day in divided one-two times
It should not exceed 3.2 gm in a day
Osteolytic bone metastases
Bonefos:
Initial dose: 1,600 mg orally every day; may be enhanced to a maximum of 3,200 mg every day
Clasteon:
1,600 mg-2,400 mg orally one time or two times a day
It should not exceed 3200 mg in a day

Administer dose of 25 to 50 mg/m2 intravenously as per body surface area (BSA) in every 3 to 4 weeks
Given as injection over 5 to 10 minutes into a rapidly flowing infusion of 5% glucose

Safety and efficacy are not studied  

Refer adult dosing

A minimum of 10 mg orally each day every 8 hours for 3 months