NEWLY APPROVED

DRUGS - 2020
BY DR. P. Renuga Devi
1ST YEAR POST GRADUATE
DEPARTMENT OF PHARMACOLOGY
SMVMCH
Puducherry
1)RELUGOLIX:
APPROVED ON: 18 Dec 2020
Gonadotropin-releasing hormone (GnRH) receptor antagonist
MOA:
Relugolix is a nonpeptide GnRH receptor antagonist (binds to pituitary GnRH
receptors)

Reduce the release of LH, FSH and consequently testosterone.

INDICATIONS:
Advanced prostate cancer.
DOSAGE
A loading dose of 360 mg on the first day of treatment followed by 120 mg taken
orally once daily
ADVERSE DRUG REACTION:
Hot flush
Hyperglycemia
Triglycerides increased
Alanine aminotransferase increased (ALT)
Aspartate aminotransferase increased (AST)
2)GALLIUM GA 68 PSMA-11:
APPROVED ON: 1 Dec 2020
INDICATIONS AND USAGE:
Ga 68 PSMA-11 Injection is indicated for positron emission tomography
(PET) of prostate-specific membrane antigen (PSMA) positive lesions in
men with prostate cancer:
• with suspected metastasis who are candidates for initial definitive
therapy.
• with suspected recurrence based on elevated serum prostate-specific
antigen (PSA) level.
DOSAGE:
Radioactivity to be administered for PET is 3 mCi to 7 mCi administered
as an intravenous bolus injection
MOA:
Binds to prostate-specific membrane antigen(including malignant
prostate cancer cells - which usually overexpress PSMA)
Gallium-68 (Ga 68) is a β+ emitting radionuclide that allows positron
emission tomography (PET).
PET images obtained using Ga 68 PSMA-11 Injection indicate the
presence of PSMA in tissues
ADR:
Nausea
Diarrhea and dizziness
3) SATRALIZUMAB:
APPROVED ON: 14 Aug 2020
INDICATIONS AND USAGE:
Rx of neuromyelitis optica spectrum disorder (NMOSD) in adult patients
who are anti-aquaporin-4 (AQP4) antibody positive
DOSAGE:
Loading dose  120 mg by SC inj. at Weeks 0, 2, and 4
Followed by a maintenance dose  120 mg every 4 weeks
MOA:
Mechanism is unknown
But is presumed to involve inhibition of IL-6-mediated signaling through
binding to soluble and membrane-bound IL-6 receptors

ADR:
• Reactivation of infection(Hepatitis B, Tuberculosis)
• Elevated Liver Enzymes(monitor for every 4 weeks for the first 3
months)
• Decreased Neutrophil Counts (monitor after 4 to 8 weeks of therapy)
• Hypersensitivity Reactions
4) VILTOLARSEN:
APPROVED ON: 12 Aug 2020
INDICATION:
Treatment of Duchenne muscular dystrophy (DMD)
DOSE:
80 mg/kg administered once weekly as a 60-minute intravenous infusion.
ADR:
• Upper respiratory tract infection
• Injection site reaction
• Cough
• Arthralgia
MOA:
It is an antisense oligonucleotide designed to bind to exon 53 of
dystrophin pre-mRNA

Resulting in exclusion of this exon during mRNA (in patients with genetic
mutations that are amenable to exon 53 skipping).

Exon 53 skipping is intended to allow for production of an internally

truncated dystrophin protein
5)OLICERIDINE:
APPROVED ON: 7 Aug 2020
INDICATIONS AND USAGE:
It is an opioid agonist
Management of acute pain severe enough where it requires an IV opioid
analgesic
DOSAGE:
Initial dose of 1.5 mg IV can be administered
Do not administer single doses > 3 mg
The cumulative daily dose should not exceed 27 mg
ADR:
Addiction, Abuse, and Misuse
Life-threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Adrenal Insufficiency
Severe Hypotension
6) RISDIPLAM:
Approved on: 10 August 2020
INDICATIONS AND USAGE:
It is a survival of motor neuron 2
Spinal muscular atrophy (SMA) in patients > 2 months of age
DOSAGE:
AGE AND BODY WEIGHT RECOMMENDED DAILY DOSAGE

2 months to less than 2 years of age 0.2 mg/kg

2 years of age and older weighing less 0.25 mg/kg

than 20 kg
2 years of age and older weighing 20 kg 5 mg
or more
MOA:
Rx patients with spinal muscular atrophy (SMA)

mutations in chromosome 5q to SMN protein deficiency.

Risdiplam, shown to increase exon 7 inclusion in SMN2 mRNA

transcripts  production of full-length SMN protein in the brain.
ADR:
• Diarrhea
• Rash
• Aphthous ulcers and Arthralgia
7) FOSTEMSAVIR:
APPROVED ON: 2 July 2020
INDICATION AND USAGE:
Rx of HIV-1 infection where there is failing of current antiretroviral
regimen due to resistance or intolerance
DOSAGE:
600 mg tablet is taken twice daily
ADR:
• Immune reconstitution syndrome
• QTc prolongation (Dose >2,400 mg)
• Elevations in hepatic transaminases in patients with hepatitis B or C
virus co-infection
MOA:
Prodrug of Temsavir

binds directly to the gp120 subunit within the HIV-1 envelope

Interaction between the virus and cellular CD4 receptors & preventing the
attachment.
8) INEBILIZUMAB:
APPROVED ON: 11 June 2020
INDICATION AND USAGE:
Rx of Neuromyelitis optica spectrum disorder (NMOSD) in adult patients
who are anti-aquaporin-4 (AQP4) antibody positive.

MOA:
Unknown
But is presumed to involve binding to CD19.
Following binding to B lymphocytes, it results in antibody-dependent
cellular cytolysis.
DOSAGE :
Initial dose: 300 mg IV infusion followed 2 weeks later by a second 300
mg intravenous infusion.
Subsequent doses: single 300 mg intravenous infusion every 6 months

ADR:
• Infusion Reactions
• Reduction in Immunoglobulins
• Decrease in lymphocyte count
9) FLORTAUCIPIR F 18 :
APPROVED ON: 28 May 2020
INDICATION AND USAGE:
Use with positron emission tomography (PET) imaging of the brain to
estimate the density and distribution of aggregated tau neurofibrillary
tangles (NFTs) in adult patients who are being evaluated for Alzheimer’s
disease (AD)
DOSAGE:
10 mCi - intravenous bolus injection
ADR:
• Headache
• Injection site pain
• Increase in blood pressure
MOA:
Following intravenous injection

Binds to NFTs.

Once bound, the radioactive decay emits pairs of 511 keV gamma
photons.

The pattern and intensity of emission  results in diagnosis of Alzheimer's

disease
10) RIPRETINIB:
APPROVED ON: 15 May 2020
INDICATION AND USAGE:
Rx of advanced gastrointestinal stromal tumor (GIST) who have received
prior treatment with 3 or more kinase inhibitors, including imatinib
MOA:
It is tyrosine kinase inhibitor
Inhibits KIT proto-oncogene receptor tyrosine kinase (KIT) and platelet
derived growth factor receptor A (PDGFRA) kinase, including wild type,
primary and secondary mutation
DOSAGE:
150 mg - once daily
ADR:
• Palmar-Plantar Erythrodysesthesia Syndrome
• New Primary Cutaneous Malignancies
• Increase in Blood Pressure
11) SELPERCATINIB:
APPROVED ON: 8 May 2020
INDICATION AND USAGE:
Treatment of adult patients with metastatic RET fusion-positive non-small
cell lung cancer (NSCLC) and RET-mutant medullary thyroid cancer
(MTC)
MOA:
Kinase inhibitor
Inhibits wild-type RET and multiple mutated RET isoforms as well as
VEGFR1 and VEGFR3
There by inhibiting cancer cell from growing
DOSAGE:
Less than 50 kg: 120 mg
50 kg or greater: 160 mg
ADR:
• Hepatotoxicity
• Hypertension
• QT Interval Prolongation
• Hemorrhagic Events
• Hypersensitivity
12) CAPMATINIB:
APPROVED ON: 6 May 2020
INDICATION AND USAGE:
Metastatic non-small cell lung cancer (NSCLC) whose tumors have a
mutation that leads to mesenchymal-epithelial transition (MET) exon 14
skipping
DOSAGE:
400 mg - Twice daily
ADR:
Hepatotoxicity
MOA:
It is a kinase inhibitor
It targets the MET, including the mutant variant produced by exon 14
skipping.
MET exon 14 skipping results in a protein with a missing regulatory
domain that reduces its negative regulation leading to increased
downstream MET signaling
There by inhibiting the cancer growth cell
13) OPICAPONE:
APPROVED ON: 24 April 2020
INDICATION AND USAGE:
Indicated as adjunctive treatment to levodopa/carbidopa in patients with
Parkinson’s disease experiencing “off” episodes.
DOSAGE:
50 mg - once daily at bedtime
ADR:
• Falling Asleep During Activities and Somnolence
• Hypotension/Syncope
• Dyskinesia
• Hallucinations
MOA:
Opicapone

Enzyme called catechol-O-methyltransferase(COMT) (breakdown of

levodopa)

Levodopa remains active for longer

Improve the symptoms of Parkinson's disease, such as stiffness and

slowness of movement
14) SACITUZUMAB GOVITECAN:
APPROVED ON: 22 April 2020
INDICATION AND USAGE:
Treatment of adult patients with metastatic triple-negative breast cancer
(mTNBC) who have received at least two prior therapies for metastatic
disease
DOSAGE:
10 mg/kg - as an intravenous infusion once weekly on Days 1 and 8 of 21-
day treatment cycles.
ADR:
• Neutropenia
• Diarrhea
• Hypersensitivity
MOA:
Trop-2-directed antibody-drug conjugate

Binds to Trop-2-expressing cancer cells interacts with topoisomerase I

and prevents re-ligation of topoisomerase I-induced single strand breaks

The resulting DNA damage leads to apoptosis and cell death

Decreases tumor growth

15) PEMIGATINIB:
APPROVED ON: 17 April 2020
INDICATION AND USAGE:
Treatment of adults with previously treated, unresectable locally advanced
or metastatic cholangiocarcinoma with a fibroblast growth factor receptor
2 (FGFR2) fusion
DOSAGE:
13.5 mg - once daily for 14 consecutive days followed by 7 days off
therapy, in 21-day cycles.
ADR:
Ocular Toxicity
Hyperphosphatemia
MOA:
Kinase inhibitor that targets FGFR1, 2 and 3

FGFRs are found on the surface of cancer cells and are involved in
the growth and spread of the cancer cells

By blocking the tyrosine kinases in FGFRs, pemigatinib is

expected to reduce the growth and spread of the cancer.
16) OSILODROSTAT:
APPROVED ON: 6 March 2020
INDICATION AND USAGE:
Treatment of adult patients with Cushing’s disease for whom pituitary
surgery is not an option or has not been curative.
DOSAGE:
1 to 2 mg twice daily.

Patient tolerates dosage of 10 mg twice daily (continues to have elevated

24-hour urine free cortisol (UFC) levels)

the dosage can be titrated further by 5 mg twice daily every 2 weeks.

ADR:
Hypocortisolism
QT Prolongation
Elevations in Adrenal Hormone Precursors and Androgens
MOA:
Osilodrostat is a cortisol synthesis inhibitor.

11beta-hydroxylase (CYP11B1) [responsible for the final step of cortisol

biosynthesis in the adrenal gland].

There by it is helpful in Cushing’s Disease

17) SARCLISA (ISATUXIMAB):
APPROVED ON: 02 March 2020
INDICATION AND USAGE:
Combination with pomalidomide and dexamethasone, in patients with
multiple myeloma who have received at least two prior therapies
including lenalidomide and a proteasome inhibitor
DOSAGE:
10 mg/kg - intravenous infusion in combination with pomalidomide and
dexamethasone
CYCLE DOSING SCHEDULE

Cycle 1 Days 1, 8, 15, and 22 (weekly)

Cycle 2 and beyond Days 1, 15 (every 2 weeks)

ADR:
Infusion-Related Reactions
Neutropenia
Second Primary Malignancies
MOA:
Isatuximab an IgG1-derived monoclonal antibody(binds to CD38
expressed on the surface of hematopoietic and tumor cells, including
MM cells).

Induces apoptosis of tumor cells and activation of immune effector

mechanisms antibody-dependent cell-mediated cytotoxicity (ADCC),
antibody-dependent cellular phagocytosis (ADCP), and complement
dependent cytotoxicity (CDC).

Isatuximab + pomalidomide ADCC activity and direct tumor cell

killing
18) TAZVERIK (tazemetostat):
APPROVED ON: 23 Jan 2020
INDICATION AND USAGE:
indicated for the treatment of age 16 years and above with metastatic or
locally advanced epithelioid sarcoma not eligible for complete resection
DOSAGE:
800 mg - twice daily
ADR:
Secondary Malignancies
MOA:
Tazemetostat is a cancer drug that acts as a potent
selective inhibitor of the methyltransferase and EZH2

Blocks activity of the EZH2 methyltransferase

Results in decreased tumor cell proliferation in EZH2 mutated

cancer cells
19) TEPEZZA (teprotumumab):
APPROVED ON: 21 Jan 2020
INDICATION AND USAGE:
Indicated for the treatment of Thyroid Eye Disease
DOSAGE:
IV infusion of 10 mg/kg for the initial dose followed by an IV infusion of
20 mg/kg every three weeks for 7 additional infusions
ADR:
Infusion Reactions
Exacerbation of Inflammatory Bowel Disease
Hyperglycemia
MOA:
Mechanism of action with Thyroid Eye Disease has not been fully
characterized.
Teprotumumab binds to IGF-1R and blocks its activation and signaling.
DRUG APPROVED INDICATION DOSE MOA ADR
ON
RELUGOLIX(GnR 12 Dec 2020 Advanced prostate LD - 360 mg on the Reduce the release Hot flush
H) receptor cancer 1st day of rx f/by of LH, FSH and Hyperglycemia
antagonist 120 mg OD consequently Increase in ALT
testosterone &AST

GALLIUM GA 68 1 Dec 2020 PET of prostate- 3 mCi to 7 mCi GA 68 bind to Nausea

PSMA-11 specific membrane PSMA On PET Diarrhea
antigen (PSMA) image  indicates
positive lesions in presence on PSMA
men with prostate in tissue
cancer

SATRALIZUMAB 14 Aug 2020 neuromyelitis optica LD - 120 mg by SC inhibition of IL-6- 1.Reactivation of

spectrum disorder at Weeks 0, 2, and 4 mediated signaling infection
MD - 120 mg every  by binding to IL 2.Elevated Liver
4 weeks – 6 receptor Enzymes
3.Decreased
Neutrophil Counts
4.Hypersensitivity
Reactions
DRUG APPROVED ON INDICATION DOSE MOA ADR

FOSTEMSAVIR 2 July 2020 HIV-1 infection 600mg BD Binds to gp120 subunit Immune
Prodrug of within the HIV-1 envelope reconstitution
Temsavir Inhibits interaction b/w the syndrome
virus and cellular CD4 QTc prolongation
receptors & preventing the
attachment

INEBILIZUMAB 11 June 2020 Neuromyelitis ID: 300 mg IV Binding to B lymphocytes Infusion Reactions
optica spectrum infusion followed 2 which results in antibody- Reduction in
disorder weeks later by a dependent cellular cytolysis Immunoglobulins
(NMOSD) second 300 mg IV Decrease in
infusion. lymphocyte count
Subsequent doses:
300 mg IV infusion
every 6 months

FLORTAUCIPIR 28 May 2020 Using PET  to 10 mCi IV Binds to NFT  reveals the Headache
F 18 find the density pattern & intensity of  Injection site pain
of NFTs in helps in diagnosis of AD Increase in blood
patients pressure
diagnosed with
AD
DRUG APPROVED INDICATION DOSE MOA ADR
ON

SELPERCATINIB 8 May 2020 metastatic RET Less than 50 kg: 120 Inhibits wild-type Hepatotoxicity
Kinase inhibitor fusion-positive mg RET, multiple Hypertension
non-small cell 50 kg or greater: 160 mutated RET QT Interval
lung cancer & mg isoforms & VEGFR1 Prolongation
RET-mutant and VEGFR3 Hemorrhagic Events
medullary inhibiting cancer Hypersensitivity
thyroid cancer cell from growing

CAPMATINIB 6 May 2020 Metastatic non- 400mg BD targets the Hepatotoxicity

small cell lung mesenchymal-
cancer (NSCLC) epithelial transition
(MET)  exon 14
skipping 
downstream signaling
 inhibits growth of
cancer cells
DRUG APPROVED INDICATION DOSE MOA ADR
ON
PEMIGATINIB 17 April 2020 advanced or 13.5 mg - OD for Targets FGFR2(on Ocular Toxicity
Kinase inhibitor metastatic 14 consecutive surface of cancer Hyperphosphatemia
cholangiocarcinoma days f/b 7 days off cell) blocking the
with a fibroblast therapy, in 21-day tyrosine kinases in
growth factor cycles. FGFRs, reduce the
receptor 2 (FGFR2) growth and spread of
fusion the cancer.

OSILODROSTAT 6 March 2020 Cushing’s disease 1-2 mg BD Inhibits CYP11B1 1.Hypocortisolism

cortisol synthesis for whom pituitary [responsible for the 2.QT Prolongation
inhibitor. surgery is not an final step of cortisol 3.Elevations in
option or has not biosynthesis in the Adrenal Hormone
been curative. adrenal gland]  Precursors and
helpful in CD Androgens

ISATUXIMAB 2 March 2020 multiple myeloma 10mg/kg IgG 1 monoclonal Infusion-Related

antibody Induces Reactions
apoptosis by Neutropenia
antibody-dependent Second Primary
cell-mediated Malignancies
cytotoxicity 
Tumour cell killing
DRUG APPROVED INDICATION DOSE MOA ADR
ON

OLICERIDINE 7 Aug 2020 Acute severe 1.5mg IV Opioid agonist 1.Addiction, Abuse, and Misuse
pain 2.Respiratory Depression
3.Withdrawal Syndrome
4.Adrenal Insufficiency
5.Severe Hypotension
SACITUZUMAB 22 April 2020 metastatic 10 mg/kg - Binds to Trop-2- 1.Neutropenia
GOVITECAN triple-negative as an IV expressing cancer cells 2.Diarrhea
Trop-2-directed breast cancer infusion interacts with 3.Hypersensitivity
antibody-drug once topoisomerase I and
conjugate weekly on prevents re-ligation of
Days 1 and topoisomerase I-induced
8 of 21-day single strand break
treatment DNA damage
cycles. apoptosis  decreased
tumor growth
VILTOLARSEN 12 Aug 2020 DMD 80mg/kg Binds to exon 53 of 1.URTI
Antisense dystrophin pre-mRNA 2.Inj. site rxn
oligonucleotide exon 53 skipping  3.Arthralgia
production of
dystrophin protein
DRUG APPROVED ON INDICATION DOSE MOA ADR

RIPRETINIB 15 May 2020 advanced 150mg OD Inhibits KIT proto- 1.Palmar-Plantar

Tyrosine kinase gastrointestinal oncogene receptor Erythrodysesthesia
inhibitor stromal tumor tyrosine kinase and Syndrome
platelet derived 2.New Primary
growth factor Cutaneous
receptor A kinase Malignancies

TEPROTUMUMAB 21 Jan 2020 Thyroid eye disease IV infusion of 10 Mechanism – 1.Infusion

mg/kg for the initial Unknown Reactions
dose f/b an IV Teprotumumab 2.Exacerbation of
infusion of 20 binds to IGF-1R IBS
mg/kg every three and blocks its 3.Hyperglycemia
weeks for 7 activation and
additional infusions signaling

OPICAPONE 24 April 2020 adjunctive rx to 50mg HS Inhibits catechol-O- 1.Somnolence

levodopa/carbidopa methyltransferase  2.Hypotension/
in patients with longer action of Syncope
Parkinson’s disease levodopa  reduces 3.Dyskinesia
experiencing “off” PD symptoms 4.Hallucinations
episodes